Trial Outcomes & Findings for D-CARE - The Dementia Care Study: A Pragmatic Clinical Trial of Health System-Based Versus Community-Based Dementia Care (NCT NCT03786471)

NCT ID: NCT03786471

Last Updated: 2025-01-30

Results Overview

The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2176 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2025-01-30

Participant Flow

Participants were referred by physicians or self-referred at 4 clinical trial sites (2 academic, 2 community-based) in 3 states. 2,176 PLwD/caregiver dyads were enrolled between June 2019 and January 2022.

Of 11,652 referred for screening, 156 were not screened due to recruitment ending, 2,929 could not be screened, 290 were unable to complete the baseline interview, 3,415 met exclusion criteria, and 2,686 declined participation.

Participant milestones

Measure	Health Systems-Based Dementia Care Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800-3900 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Overall Study STARTED	1016	1016	144
Overall Study Completed 3-month Interview	830	872	120
Overall Study Completed 6-month Interview	804	821	112
Overall Study Completed 12-month Interview	702	733	93
Overall Study COMPLETED	600	662	81
Overall Study NOT COMPLETED	416	354	63

Reasons for withdrawal

Measure	Health Systems-Based Dementia Care Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800-3900 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Overall Study Death	254	223	37
Overall Study Lost to Follow-up	63	50	15
Overall Study Withdrawal by Subject	99	81	11

Baseline Characteristics

D-CARE - The Dementia Care Study: A Pragmatic Clinical Trial of Health System-Based Versus Community-Based Dementia Care

Baseline characteristics by cohort

Measure	Health Systems-Based Dementia Care n=1016 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=1016 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=144 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800-3900 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control	Total n=2176 Participants Total of all reporting groups
Age, Continuous Caregiver Age	64.8 years STANDARD_DEVIATION 12.3 • n=5 Participants	65.6 years STANDARD_DEVIATION 12.3 • n=7 Participants	66.2 years STANDARD_DEVIATION 11.7 • n=5 Participants	65.2 years STANDARD_DEVIATION 12.3 • n=4 Participants
Age, Continuous PLWD Age	80.6 years STANDARD_DEVIATION 8.3 • n=5 Participants	80.6 years STANDARD_DEVIATION 8.7 • n=7 Participants	81.0 years STANDARD_DEVIATION 8.4 • n=5 Participants	80.6 years STANDARD_DEVIATION 8.5 • n=4 Participants
Sex: Female, Male PLWD Sex · Female	611 Participants n=5 Participants	583 Participants n=7 Participants	77 Participants n=5 Participants	1271 Participants n=4 Participants
Sex: Female, Male PLWD Sex · Male	405 Participants n=5 Participants	433 Participants n=7 Participants	67 Participants n=5 Participants	905 Participants n=4 Participants
Sex: Female, Male Caregiver Sex · Female	772 Participants n=5 Participants	760 Participants n=7 Participants	118 Participants n=5 Participants	1650 Participants n=4 Participants
Sex: Female, Male Caregiver Sex · Male	244 Participants n=5 Participants	256 Participants n=7 Participants	26 Participants n=5 Participants	526 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	95 Participants n=5 Participants	94 Participants n=7 Participants	16 Participants n=5 Participants	205 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	919 Participants n=5 Participants	922 Participants n=7 Participants	128 Participants n=5 Participants	1969 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	124 Participants n=5 Participants	115 Participants n=7 Participants	20 Participants n=5 Participants	259 Participants n=4 Participants
Race (NIH/OMB) White	847 Participants n=5 Participants	873 Participants n=7 Participants	119 Participants n=5 Participants	1839 Participants n=4 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	24 Participants n=5 Participants	16 Participants n=7 Participants	3 Participants n=5 Participants	43 Participants n=4 Participants
Region of Enrollment United States	1016 dyads n=5 Participants	1016 dyads n=7 Participants	144 dyads n=5 Participants	2176 dyads n=4 Participants
Caregiver Education Less than HS graduate	39 Participants n=5 Participants	28 Participants n=7 Participants	1 Participants n=5 Participants	68 Participants n=4 Participants
Caregiver Education HS graduate or GED	172 Participants n=5 Participants	164 Participants n=7 Participants	22 Participants n=5 Participants	358 Participants n=4 Participants
Caregiver Education Some college or equivalent	303 Participants n=5 Participants	301 Participants n=7 Participants	43 Participants n=5 Participants	647 Participants n=4 Participants
Caregiver Education Graduated from college	302 Participants n=5 Participants	327 Participants n=7 Participants	46 Participants n=5 Participants	675 Participants n=4 Participants
Caregiver Education Graduate or professional degree	200 Participants n=5 Participants	196 Participants n=7 Participants	32 Participants n=5 Participants	428 Participants n=4 Participants
Caregiver Education Unknown or not reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
PLWD Education Less than HS graduate	167 Participants n=5 Participants	154 Participants n=7 Participants	18 Participants n=5 Participants	339 Participants n=4 Participants
PLWD Education HS graduate or GED	267 Participants n=5 Participants	312 Participants n=7 Participants	48 Participants n=5 Participants	627 Participants n=4 Participants
PLWD Education Some college or equivalent	238 Participants n=5 Participants	238 Participants n=7 Participants	35 Participants n=5 Participants	511 Participants n=4 Participants
PLWD Education Graduated from college	206 Participants n=5 Participants	168 Participants n=7 Participants	21 Participants n=5 Participants	395 Participants n=4 Participants
PLWD Education Graduate or professional degree	136 Participants n=5 Participants	144 Participants n=7 Participants	20 Participants n=5 Participants	300 Participants n=4 Participants
PLWD Education Unknown or not reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Caregiver Primary Language English	1011 Participants n=5 Participants	1004 Participants n=7 Participants	144 Participants n=5 Participants	2159 Participants n=4 Participants
Caregiver Primary Language Spanish	5 Participants n=5 Participants	12 Participants n=7 Participants	0 Participants n=5 Participants	17 Participants n=4 Participants
Persons Living with Dementia (PLWD) Primary Language English	999 Participants n=5 Participants	995 Participants n=7 Participants	142 Participants n=5 Participants	2136 Participants n=4 Participants
Persons Living with Dementia (PLWD) Primary Language Spanish	17 Participants n=5 Participants	21 Participants n=7 Participants	2 Participants n=5 Participants	40 Participants n=4 Participants
Caregiver Marital Status Married/Partner	780 Participants n=5 Participants	799 Participants n=7 Participants	118 Participants n=5 Participants	1697 Participants n=4 Participants
Caregiver Marital Status Widowed	25 Participants n=5 Participants	27 Participants n=7 Participants	1 Participants n=5 Participants	53 Participants n=4 Participants
Caregiver Marital Status Divorced	97 Participants n=5 Participants	98 Participants n=7 Participants	13 Participants n=5 Participants	208 Participants n=4 Participants
Caregiver Marital Status Single	105 Participants n=5 Participants	84 Participants n=7 Participants	9 Participants n=5 Participants	198 Participants n=4 Participants
Caregiver Marital Status Other	9 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	20 Participants n=4 Participants
PLWD Marital Status Married/Partner	547 Participants n=5 Participants	546 Participants n=7 Participants	78 Participants n=5 Participants	1171 Participants n=4 Participants
PLWD Marital Status Widowed	322 Participants n=5 Participants	346 Participants n=7 Participants	51 Participants n=5 Participants	719 Participants n=4 Participants
PLWD Marital Status Divorced	99 Participants n=5 Participants	97 Participants n=7 Participants	12 Participants n=5 Participants	208 Participants n=4 Participants
PLWD Marital Status Single	40 Participants n=5 Participants	22 Participants n=7 Participants	3 Participants n=5 Participants	65 Participants n=4 Participants
PLWD Marital Status Other	8 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	13 Participants n=4 Participants
Caregiver living with PLWD Yes	728 Participants n=5 Participants	755 Participants n=7 Participants	105 Participants n=5 Participants	1588 Participants n=4 Participants
Caregiver living with PLWD No	287 Participants n=5 Participants	261 Participants n=7 Participants	39 Participants n=5 Participants	587 Participants n=4 Participants
Caregiver living with PLWD Unknown or not reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
PLWD Living Arrangement At home alone without caregiver	139 Participants n=5 Participants	130 Participants n=7 Participants	21 Participants n=5 Participants	290 Participants n=4 Participants
PLWD Living Arrangement At home with caregiver	723 Participants n=5 Participants	753 Participants n=7 Participants	105 Participants n=5 Participants	1581 Participants n=4 Participants
PLWD Living Arrangement At home with someone else	97 Participants n=5 Participants	83 Participants n=7 Participants	9 Participants n=5 Participants	189 Participants n=4 Participants
PLWD Living Arrangement Assisted Living Facility	57 Participants n=5 Participants	50 Participants n=7 Participants	9 Participants n=5 Participants	116 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline

The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at baseline.

Outcome measures

Measure	Health Systems-Based Dementia Care n=992 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=990 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=140 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Severity of Dementia-related Behavioral Symptoms	10.32 score on a scale Standard Error 0.22	9.93 score on a scale Standard Error 0.21	10.42 score on a scale Standard Error 0.56

PRIMARY outcome

Timeframe: 3-month

The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 3 month.

Outcome measures

Measure	Health Systems-Based Dementia Care n=776 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=831 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=114 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Severity of Dementia-related Behavioral Symptoms	9.10 score on a scale Standard Error 0.24	8.98 score on a scale Standard Error 0.22	9.67 score on a scale Standard Error 0.65

PRIMARY outcome

Timeframe: 6-month

The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 6 months.

Outcome measures

Measure	Health Systems-Based Dementia Care n=764 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=784 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=107 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Severity of Dementia-related Behavioral Symptoms	9.41 score on a scale Standard Error .25	8.78 score on a scale Standard Error .23	9.93 score on a scale Standard Error .68

PRIMARY outcome

Timeframe: 12-month

The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 12 months.

Outcome measures

Measure	Health Systems-Based Dementia Care n=665 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=685 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=87 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Severity of Dementia-related Behavioral Symptoms	9.58 score on a scale Standard Error .27	9.14 score on a scale Standard Error .25	9.95 score on a scale Standard Error .74

PRIMARY outcome

Timeframe: 18-month

The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 18 months.

Outcome measures

Measure	Health Systems-Based Dementia Care n=564 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=620 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=75 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Severity of Dementia-related Behavioral Symptoms	9.80 score on a scale Standard Error 0.29	9.51 score on a scale Standard Error 0.27	9.60 score on a scale Standard Error 0.79

PRIMARY outcome

Timeframe: Baseline

The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the least squares mean of the baseline "treatment 0", which can be compared to the overall follow-up least square means to estimate treatment effects in each arm.

Outcome measures

Measure	Health Systems-Based Dementia Care n=2166 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Severity of Dementia-related Behavioral Symptoms (Common Baseline)	10.07 score on a scale Interval 9.71 to 10.43	—	—

PRIMARY outcome

Timeframe: Average of 3M, 6M, 12M, and 18M least square means.

The severity of symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Severity (NPI-Q Severity). The NPI-Q Severity is a validated survey that assesses the caregiver's perception of the severity of 12 dementia-related psychiatric and behavioral symptoms. NPI-Q Severity score ranges from 0-36 with higher scores indicating more severe symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents those average least squares means across all follow-up times for each arm.

Outcome measures

Measure	Health Systems-Based Dementia Care n=1012 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=1011 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=143 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Severity of Dementia-related Behavioral Symptoms	9.79 score on a scale Interval 9.37 to 10.22	9.50 score on a scale Interval 9.08 to 9.91	10.12 score on a scale Interval 9.15 to 11.08

PRIMARY outcome

Timeframe: Baseline

The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at baseline.

Outcome measures

Measure	Health Systems-Based Dementia Care n=1004 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=1007 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=141 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Caregiver Distress/Strain	11.03 score on a scale Standard Error 0.20	10.65 score on a scale Standard Error 0.19	11.13 score on a scale Standard Error 0.55

PRIMARY outcome

Timeframe: 3-month

The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 3 months.

Outcome measures

Measure	Health Systems-Based Dementia Care n=820 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=855 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=120 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Caregiver Distress/Strain	10.52 score on a scale Standard Error 0.22	10.01 score on a scale Standard Error 0.20	10.00 score on a scale Standard Error 0.53

PRIMARY outcome

Timeframe: 6-month

The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 6 months.

Outcome measures

Measure	Health Systems-Based Dementia Care n=790 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=809 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=112 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Caregiver Distress/Strain	10.61 score on a scale Standard Error 0.23	10.26 score on a scale Standard Error 0.22	10.53 score on a scale Standard Error 0.65

PRIMARY outcome

Timeframe: 12-month

The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 12 months.

Outcome measures

Measure	Health Systems-Based Dementia Care n=685 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=716 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=92 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Caregiver Distress/Strain	11.00 score on a scale Standard Error 0.24	10.50 score on a scale Standard Error 0.24	10.41 score on a scale Standard Error 0.69

PRIMARY outcome

Timeframe: 18-month

The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 18 months.

Outcome measures

Measure	Health Systems-Based Dementia Care n=584 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=646 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=79 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Caregiver Distress/Strain	11.26 score on a scale Standard Error 0.26	10.64 score on a scale Standard Error 0.24	10.32 score on a scale Standard Error 0.72

PRIMARY outcome

Timeframe: Baseline

The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the least squares mean of the baseline "treatment 0", which can be compared to the overall follow-up least square means to estimate treatment effects in each arm.

Outcome measures

Measure	Health Systems-Based Dementia Care n=2171 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Caregiver Distress/Strain (Common Baseline)	10.61 score on a scale Interval 10.29 to 10.93	—	—

PRIMARY outcome

Timeframe: Average of 3M, 6M, 12M, and 18M least square means

The level of caregiver distress/strain as measured by the Modified Caregiver Strain Index (MCSI). The MCSI is a 13-item validated tool used to assess severity of caregiver strain. The index targets financial, physical, psychological, and social aspects of strain and is scored from 0 to 26 with higher scores indicating greater levels of strain. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents those average least squares means across all follow-up times for each arm.

Outcome measures

Measure	Health Systems-Based Dementia Care n=1013 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=1014 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=144 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Caregiver Distress/Strain	10.74 score on a scale Interval 10.36 to 11.12	10.50 score on a scale Interval 10.12 to 10.87	10.60 score on a scale Interval 9.77 to 11.42

SECONDARY outcome

Timeframe: Baseline

Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at baseline.

Outcome measures

Measure	Health Systems-Based Dementia Care n=996 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=991 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=141 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms	12.96 score on a scale Standard Error 0.32	12.66 score on a scale Standard Error 0.31	12.69 score on a scale Standard Error 0.79

SECONDARY outcome

Timeframe: 3-month

Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 3 months.

Outcome measures

Measure	Health Systems-Based Dementia Care n=793 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=834 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=114 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms	11.45 score on a scale Standard Error 0.35	11.15 score on a scale Standard Error 0.32	12.42 score on a scale Standard Error 0.91

SECONDARY outcome

Timeframe: 6-month

Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 6 months.

Outcome measures

Measure	Health Systems-Based Dementia Care n=763 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=785 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=106 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms	11.88 score on a scale Standard Error 0.37	11.23 score on a scale Standard Error 0.34	12.62 score on a scale Standard Error 0.95

SECONDARY outcome

Timeframe: 12-month

Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 12 months.

Outcome measures

Measure	Health Systems-Based Dementia Care n=666 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=686 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=86 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms	12.09 score on a scale Standard Error 0.39	11.76 score on a scale Standard Error 0.37	12.63 score on a scale Standard Error 1.02

SECONDARY outcome

Timeframe: 18-month

Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 18 months.

Outcome measures

Measure	Health Systems-Based Dementia Care n=564 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=622 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=75 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms	12.12 score on a scale Standard Error 0.43	11.80 score on a scale Standard Error 0.40	11.53 score on a scale Standard Error 1.12

SECONDARY outcome

Timeframe: Baseline

Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the least squares mean of the baseline "treatment 0", which can be compared to the overall follow-up least square means to estimate treatment effects in each arm.

Outcome measures

Measure	Health Systems-Based Dementia Care n=2166 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms (Common Baseline)	12.62 score on a scale Interval 12.16 to 13.08	—	—

SECONDARY outcome

Timeframe: Average of 3M, 6M, 12M, and 18M least square means

Distress of caregivers due to the symptoms of psychopathology in persons with dementia as measured by the Neuro-Psychiatric Inventory Questionnaire - Distress (NPI-Q Distress). The NPI-Q Distress scale is a validated survey that assesses the level of distress experienced by the caregiver in response to dementia-related psychiatric and behavioral symptoms. NPI-Q Distress score ranges from 0-60 with higher scores indicating more severe distress. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents those average least squares means across all follow-up times for each arm.

Outcome measures

Measure	Health Systems-Based Dementia Care n=1013 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=1010 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=143 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Level of Distress Experienced by the Caregiver in Response to Dementia-related Psychiatric and Behavioral Symptoms	12.29 score on a scale Interval 11.76 to 12.83	11.77 score on a scale Interval 11.25 to 12.3	13.10 score on a scale Interval 11.88 to 14.32

SECONDARY outcome

Timeframe: Baseline

The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores >10 indicating moderate symptoms and scores >20 indicating severe depressive symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at baseline.

Outcome measures

Measure	Health Systems-Based Dementia Care n=1009 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=1009 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=144 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Severity of Depression in Caregivers	4.72 score on a scale Standard Error 0.15	4.78 score on a scale Standard Error 0.15	5.17 score on a scale Standard Error .40

SECONDARY outcome

Timeframe: 3-month

The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores >10 indicating moderate symptoms and scores >20 indicating severe depressive symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 3 months.

Outcome measures

Measure	Health Systems-Based Dementia Care n=825 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=866 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=120 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Severity of Depression in Caregivers	4.47 score on a scale Standard Error 0.16	4.40 score on a scale Standard Error .15	4.68 score on a scale Standard Error .41

SECONDARY outcome

Timeframe: 6-month

The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores >10 indicating moderate symptoms and scores >20 indicating severe depressive symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 6 months.

Outcome measures

Measure	Health Systems-Based Dementia Care n=788 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=813 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=112 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Severity of Depression in Caregivers	4.55 score on a scale Standard Error .16	4.26 score on a scale Standard Error .15	4.57 score on a scale Standard Error .42

SECONDARY outcome

Timeframe: 12-month

The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores >10 indicating moderate symptoms and scores >20 indicating severe depressive symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 12 months.

Outcome measures

Measure	Health Systems-Based Dementia Care n=685 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=719 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=92 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Severity of Depression in Caregivers	4.46 score on a scale Standard Error .17	4.41 score on a scale Standard Error .17	4.66 score on a scale Standard Error .48

SECONDARY outcome

Timeframe: 18-month

The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores >10 indicating moderate symptoms and scores >20 indicating severe depressive symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 18 months.

Outcome measures

Measure	Health Systems-Based Dementia Care n=586 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=649 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=80 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Severity of Depression in Caregivers	4.34 score on a scale Standard Error 0.18	4.39 score on a scale Standard Error 0.17	4.19 score on a scale Standard Error 0.43

SECONDARY outcome

Timeframe: Baseline

The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores >10 indicating moderate symptoms and scores >20 indicating severe depressive symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the least squares mean of the baseline "treatment 0", which can be compared to the overall follow-up least square means to estimate treatment effects in each arm.

Outcome measures

Measure	Health Systems-Based Dementia Care n=2174 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Severity of Depression in Caregivers (Common Baseline)	4.72 score on a scale Interval 4.52 to 4.95	—	—

SECONDARY outcome

Timeframe: Average of 3M, 6M, 12M, and 18M least square means

The severity of depression in caregivers as measured by the Patient Health Questionnaire (PHQ-8). PHQ-8 is an 8-item validated tool used to assess depressive symptoms in the caregiver using the Diagnostic and Statistical Manual IV (DSM-IV) criteria for major depression and is scored from 0-24 with scores >10 indicating moderate symptoms and scores >20 indicating severe depressive symptoms. The analyses are comparisons between each arm's average of its 3-month, 6-month, 12-month, and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents those average least squares means across all follow-up times for each arm.

Outcome measures

Measure	Health Systems-Based Dementia Care n=1016 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=1014 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=144 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Severity of Depression in Caregivers	4.70 score on a scale Interval 4.47 to 4.94	4.42 score on a scale Interval 4.19 to 4.66	4.69 score on a scale Interval 4.17 to 5.22

SECONDARY outcome

Timeframe: Baseline

Caregivers' ability to manage dementia-related problems and ability to access help is measured with a 4-item self-efficacy scale [range, 1 (strongly disagree) to 5 (strongly agree)] measuring the caregiver's self-efficacy for caring for the patient with dementia and for accessing help, including community resources. The scores for each of the 4 items are summed to produce an overall caregiver self-efficacy score ranging from 4-20 with higher scores indicating better caregiver self-efficacy. The analyses are comparisons between each arm's average of its 6-month and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at baseline.

Outcome measures

Measure	Health Systems-Based Dementia Care n=1011 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=1011 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=143 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Caregiver Self-Efficacy: 4-item Self-efficacy Scale	13.26 score on a scale Standard Error .10	13.12 score on a scale Standard Error .10	13.17 score on a scale Standard Error .25

SECONDARY outcome

Timeframe: 6-month

Caregivers' ability to manage dementia-related problems and ability to access help is measured with a 4-item self-efficacy scale [range, 1 (strongly disagree) to 5 (strongly agree)] measuring the caregiver's self-efficacy for caring for the patient with dementia and for accessing help, including community resources. The scores for each of the 4 items are summed to produce an overall caregiver self-efficacy score ranging from 4-20 with higher scores indicating better caregiver self-efficacy. The analyses are comparisons between each arm's average of its 6-month and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 6 months.

Outcome measures

Measure	Health Systems-Based Dementia Care n=793 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=812 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=112 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Caregiver Self-Efficacy: 4-item Self-efficacy Scale	15.01 score on a scale Standard Error 0.10	15.00 score on a scale Standard Error 0.10	14.29 score on a scale Standard Error 0.32

SECONDARY outcome

Timeframe: 18-month

Caregivers' ability to manage dementia-related problems and ability to access help is measured with a 4-item self-efficacy scale [range, 1 (strongly disagree) to 5 (strongly agree)] measuring the caregiver's self-efficacy for caring for the patient with dementia and for accessing help, including community resources. The scores for each of the 4 items are summed to produce an overall caregiver self-efficacy score ranging from 4-20 with higher scores indicating better caregiver self-efficacy. The analyses are comparisons between each arm's average of its 6-month and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the means of the raw outcome data for each arm at 18 months.

Outcome measures

Measure	Health Systems-Based Dementia Care n=584 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=648 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=80 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Caregiver Self-Efficacy: 4-item Self-efficacy Scale	15.09 score on a scale Standard Error 0.11	15.36 score on a scale Standard Error 0.11	14.66 score on a scale Standard Error 0.35

SECONDARY outcome

Timeframe: Baseline

Caregivers' ability to manage dementia-related problems and ability to access help is measured with a 4-item self-efficacy scale [range, 1 (strongly disagree) to 5 (strongly agree)] measuring the caregiver's self-efficacy for caring for the patient with dementia and for accessing help, including community resources. The scores for each of the 4 items are summed to produce an overall caregiver self-efficacy score ranging from 4-20 with higher scores indicating better caregiver self-efficacy. The analyses are comparisons between each arm's average of its 6 and 18 months least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents the least squares mean of the baseline "treatment 0", which can be compared to the overall follow-up least square means to estimate treatment effects in each arm.

Outcome measures

Measure	Health Systems-Based Dementia Care n=2172 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Caregiver Self-Efficacy: 4-item Self-efficacy Scale (Common Baseline)	13.24 score on a scale Interval 13.1 to 13.39	—	—

SECONDARY outcome

Timeframe: Average of 6M and 18M least square means

Caregivers' ability to manage dementia-related problems and ability to access help is measured with a 4-item self-efficacy scale [range, 1 (strongly disagree) to 5 (strongly agree)] measuring the caregiver's self-efficacy for caring for the patient with dementia and for accessing help, including community resources. The scores for each of the 4 items are summed to produce an overall caregiver self-efficacy score ranging from 4-20 with higher scores indicating better caregiver self-efficacy. The analyses are comparisons between each arm's average of its 6-month and 18-month least squares means using a constrained longitudinal model that assigns all baseline data to a common "treatment 0." This entry presents those average least squares means across all follow-up times for each arm.

Outcome measures

Measure	Health Systems-Based Dementia Care n=1013 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=1015 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=144 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Caregiver Self-Efficacy: 4-item Self-efficacy Scale	15.06 score on a scale Interval 14.89 to 15.23	15.22 score on a scale Interval 15.05 to 15.38	14.36 score on a scale Interval 13.95 to 14.78

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: PLWD with completed MoCA at baseline

Cognition as measured by the Montreal Cognitive Assessment (MoCA). MoCA is a validated widely used test of cognition that captures mild cognitive impairment as well as dementia. This will be collected at baseline by telephone and at the end of the study at 18 months to document disease progression.

To reduce respondent burden and missing data, we will use a shortened 3-item form (a 0-12 point scale for evaluating memory, verbal fluency, and orientation only) for reporting study participant baseline characteristics and measuring the decline in cognition. Higher scores indicate less impairment. Participants who score 8 or higher on the shortened version will receive the full 22-item telephone MOCA to determine whether they have capacity to provide informed consent.

This entry presents the means of the raw outcome data for each arm among PLWD who completed MoCA at baseline.

Outcome measures

Measure	Health Systems-Based Dementia Care n=704 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=709 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=99 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Cognition of Persons Living With Dementia	6.2 score on a scale Standard Deviation 5.7	6.4 score on a scale Standard Deviation 6.0	5.9 score on a scale Standard Deviation 5.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: PLWD with missing MoCA at baseline

Cognition as measured by the Montreal Cognitive Assessment (MoCA). MoCA is a validated widely used test of cognition that captures mild cognitive impairment as well as dementia. This will be collected at baseline by telephone and at the end of the study to document disease progression.

To reduce respondent burden and missing data, we will use a shortened 3-item form (a 0-12 point scale for evaluating memory, verbal fluency, and orientation only) for reporting study participant baseline characteristics and measuring the decline in cognition. Participants who score 8 or higher on the shortened version will receive the full 22-item telephone MOCA to determine whether they have capacity to provide informed consent.

Report is among PLWD with missing MoCA at baseline.

Outcome measures

Measure	Health Systems-Based Dementia Care n=312 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=307 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=45 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Cognition of Persons Living With Dementia (Missing Data) Participant refusal	125 Participants	131 Participants	21 Participants
Cognition of Persons Living With Dementia (Missing Data) Hearing impairment	115 Participants	121 Participants	15 Participants
Cognition of Persons Living With Dementia (Missing Data) Clinical decision	52 Participants	39 Participants	7 Participants
Cognition of Persons Living With Dementia (Missing Data) Partial data	20 Participants	16 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: PLWD with completed FAQ at baseline

Functional status measured using the Functional Activities Questionnaire (FAQ). FAQ ranges from 0 to 30 with higher scores indicating more functional dependence. FAQ outcomes were collected at baseline and at 18 months. This entry presents the means of the raw outcome data for each arm at baseline.

Outcome measures

Measure	Health Systems-Based Dementia Care n=999 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=997 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=143 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Functional Status Measured by FAQ	21.4 score on a scale Standard Deviation 7.5	21.3 score on a scale Standard Deviation 7.2	21.0 score on a scale Standard Deviation 8.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: PLWD with completed Katz at baseline

Functional status measured using Katz' Index of Independence in Activities of Daily Living (ADL) ranges from 0 to 6 with higher scores indicating more functional independence. Outcomes were collected at baseline and at 18 months. This entry presents the means of the raw outcome data for each arm at baseline.

Outcome measures

Measure	Health Systems-Based Dementia Care n=1013 Participants Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=1010 Participants Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=144 Participants Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Functional Status Measured by ADLs	4.4 score on a scale Standard Deviation 1.9	4.5 score on a scale Standard Deviation 1.8	4.5 score on a scale Standard Deviation 1.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Asks patients & caregivers to select their most important goal and assesses their progress towards meeting it as a result of one of the study's intervention. Goal attainment, defined as whether a person's individual goals are achieved as a result of the study intervention, will be measured using a 5-point goal attainment scale (GAS). GAS describes the person's expected level of goal achievement over a specified timeframe, ranging from much worse than expected (scored as -2) to much better than expected (scored as +2). Scales are dynamically set according to a person's needs, while measurement of attainment is standardized. The outcome will be a least squares marginal mean based on follow-up measurements at 6 and 18 months.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Mortality of persons with dementia as measured by interviews with caregivers at 3, 6, 12, and 18 months. Data will be verified using the Center for Medicare and Medicaid Services at 18 months. For participants who did not complete the 18-month interview, vital status will be investigated using the electronic health records (EHR).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Time spent at home is defined as [number of days since randomization - (number of inpatient days spent at an acute care hospital, inpatient rehabilitation facility, skill nursing facility, long-term care facility, or inpatient hospice unit)/Number of days since randomization].

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Caregiver Rating of Dementia Care Quality is a composite instrument of 10 items (with yes or no responses) from the Assessing Care of Vulnerable Elders (ACOVE), Physician Consortium for Performance Improvement (PCPI) and the American Academy of Neurology (AAN) quality measures. The outcome is a count of the number of yes responses (range 0-10, higher counts indicate greater caregiver rating of satisfaction of dementia care quality).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Caregiver's satisfaction with the dementia care program is measured using a 11-item questionnaire, modified from the University of California Los Angeles' Alzheimer's and Dementia Care program, with ranges from 11 to 55 (higher scores indicate greater caregiver satisfaction with the dementia care program). The questionnaire will be administered at 3, 12 and 18 months.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Dementia Burden Scale-Caregiver (DBS-CG) is a composite of the NPI-Q Distress, MCSI, and PHQ-8 scales with items transformed linearly to be on a 0-100 possible range and then averaged with higher scores indicating higher caregiver burden. The minimal clinically important difference (MCID) for the DBS-CG is 5 points. The outcome will be a least squares marginal mean based on follow-up measurements at 3, 6, 12 and 18 months.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Clinical benefit is a binary measure of patient symptoms using the NPI-Q severity scale (the only patient outcome anticipated to benefit from the program) and caregiver symptoms using the DBS-CG scale. Benefit on the NPI-Q severity scale is defined as having a 1-year score of less than or equal to 6 (the lowest tertile of symptoms) or improving by at least 3 points, the MCID. DBS-CG benefit is defined as having a 1-year score of less than or equal to 18.8 (the lowest tertile of symptoms) or improving by at least 5 points, the MCID. Defining benefit in this manner captures both preventive (those who have few symptoms at baseline and do not deteriorate) and therapeutic (those who improve) benefit from the program. The outcome will be an overall odds ratio based on follow-up measurements at 3, 6, 12 and 18 months.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Quality of life as measured by the Quality of Life in Alzheimer's Disease (QOL-AD). The QOL-AD is a 13-item instrument scored 4-52 (higher scores indicate better quality of life) that can be administered to persons with dementia and caregivers. It has demonstrated sensitivity to psychosocial intervention correlates with health-utility measures, is widely translated and used internationally and can be used by people with Mini-Mental State Exam (MMSE) scores as low as three. The outcome will be measured at 18 months.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

The positive aspects of family caregiving as measured by the Positive Aspects of Family Caregiving Questionnaire, which is an 11-item tool to assess favorable aspects of caregiving experiences, and is scored from 0 to 44 (most positive) with higher scores indicating a more positive mental and affective state related to the caregiver's experience. The outcome will be measured at 6 months.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Inpatient Days Spent at an Acute Care Hospital is defined as the number of days an individual is admitted to an acute care hospital. This outcome will be attained using data from the Centers for Medicare and Medicaid Services (CMS).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Inpatient Days Spent at an Inpatient Rehabilitation Facility is defined as the number of days an individual is admitted to an inpatient rehabilitation facility. This outcome will be attained using data from CMS.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Inpatient Days Spent at a Skilled Nursing Facility is defined as the number of days an individual is admitted to a Skilled Nursing Facility. This outcome will be attained using data from CMS.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Inpatient Days Spent at a Long-term Care Facility is defined as the number of days an individual is admitted to a Long-term Care Facility. This outcome will be attained using data from CMS.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Placement in a Long-term Care Facility is defined by (1) observed placement in a long-term care facility, or (2) the time (days) from enrollment to when individual is admitted to a Long-term Care Facility. This outcome will be attained using data from CMS.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Days Spent Receiving Hospice Benefit is defined as the number of days an individual is receiving hospice care regardless of location. This outcome will be attained using data from CMS.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

The level of physician satisfaction with dementia care programs as measured by the Physician Assessment of Dementia Care (PADC). The PADC is an 5-item questionnaire modified from UCLA's Alzheimer's and Dementia Care program. Each item will be examined individually (with the range of each item differing). The questionnaire will be administered at 18 months, when the provider's first enrolled patient completes the study. All providers with at least one enrolled patient in the study will be surveyed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

The cost-effectiveness of the interventions compared to usual care is the ratio of incremental net costs to incremental effects of the NPI-Q-Severity. Thus, the ratio will be the net costs per unit change in NPI-Q-Severity. Costs will be taken from the perspective of Medicare. The net costs of the interventions are the costs of training for and doing the intervention less the cost offsets of reduced medical care and caregiving, if any, they bring about. The intervention costs, primarily labor, will be collected at the sites.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

The cost-effectiveness of the interventions compared to usual care is the ratio of incremental net costs to incremental effects of the Modified Caregiver Strain Index (MCSI). Thus, the ratio will be the net costs per unit change in MCSI. Costs will be taken from the perspective of Medicare. The net costs of the interventions are the costs of training for and doing the intervention less the cost offsets of reduced medical care and caregiving, if any, they bring about. The intervention costs, primarily labor, will be collected at the sites.

Outcome measures

Outcome data not reported

Adverse Events

Health Systems-Based Dementia Care

Serious events: 528 serious events

Other events: 0 other events

Deaths: 254 deaths

Community-Based Dementia Care

Serious events: 533 serious events

Other events: 0 other events

Deaths: 223 deaths

Usual Care

Serious events: 70 serious events

Other events: 0 other events

Deaths: 37 deaths

Serious adverse events

Measure	Health Systems-Based Dementia Care n=1016 participants at risk Dementia care that is based in the health care system, which partners with community-based organizations to provide comprehensive, coordinated, patient-centered care. The health system-based dementia care arm uses a Dementia Care Specialist (Nurse Practitioner or Physician Assistant) supervised by a physician to tailor and facilitate dementia care delivery in collaboration with the primary care physician (co-management). The Health Systems-Based Dementia Care arm is based on UCLA's Alzheimer's and Dementia Care Program. Health System-based Dementia Care: Active comparator	Community-Based Dementia Care n=1016 participants at risk Dementia care that is based in community organizations, which gives equal attention to patients and their primary family or friend caregivers. The community-based dementia care arm uses Care Consultants (social workers, nurses, or licensed therapist). Patients with dementia are engaged in the program whenever possible. Caregivers can be the sole program participant, when patients are too impaired. The program establishes a long-term relationship between Care Consultants and families. The exact content of assistance provided is tailored to the preferences of individual patients and caregivers, and is holistic in the range of potential concerns of problems addressed. The Community-Based Dementia Care arm is based on the Benjamin Rose Institute on Aging's Care Consultation Program. Community-based Dementia Care: Active comparator	Usual Care n=144 participants at risk Dementia care that most closely corresponds to traditional care. This arm will also receive standardized educational materials (hard copies and internet-based resources), referral to the Alzheimer's Association 1-800 national helpline to speak to a master's level consultant for decision-making support, crisis assistance, and caregiver education, as well as referral to local programs and services. Usual Care: Control
Immune system disorders Allergic	0.20% 2/1016 • Number of events 2 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.10% 1/1016 • Number of events 2 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/144 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Infections and infestations COVID-19	2.1% 21/1016 • Number of events 26 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	2.6% 26/1016 • Number of events 32 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	2.1% 3/144 • Number of events 3 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Cardiac disorders Cardiopulmonary	0.10% 1/1016 • Number of events 1 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/1016 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/144 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Infections and infestations Cardiopulmonary	0.10% 1/1016 • Number of events 1 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/1016 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/144 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Respiratory, thoracic and mediastinal disorders Cardiopulmonary	3.1% 31/1016 • Number of events 36 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	3.1% 31/1016 • Number of events 41 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	1.4% 2/144 • Number of events 2 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Endocrine disorders Endocrine or Metabolic	0.98% 10/1016 • Number of events 14 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.30% 3/1016 • Number of events 3 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.69% 1/144 • Number of events 1 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Musculoskeletal and connective tissue disorders Falls or fractures	9.6% 98/1016 • Number of events 118 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	8.1% 82/1016 • Number of events 101 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	5.6% 8/144 • Number of events 9 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Gastrointestinal disorders Gastroenterologic	2.6% 26/1016 • Number of events 30 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	3.4% 35/1016 • Number of events 43 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	5.6% 8/144 • Number of events 8 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Hepatobiliary disorders Hematologic	0.20% 2/1016 • Number of events 2 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.49% 5/1016 • Number of events 7 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	1.4% 2/144 • Number of events 2 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Infections and infestations Infection	8.7% 88/1016 • Number of events 110 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	7.1% 72/1016 • Number of events 108 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	9.0% 13/144 • Number of events 18 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Nervous system disorders Neurologic	6.2% 63/1016 • Number of events 79 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	7.5% 76/1016 • Number of events 86 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	8.3% 12/144 • Number of events 14 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Psychiatric disorders Neuropsychiatric complications of dementia	1.8% 18/1016 • Number of events 20 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	1.6% 16/1016 • Number of events 19 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.69% 1/144 • Number of events 1 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncologic	0.30% 3/1016 • Number of events 5 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.59% 6/1016 • Number of events 8 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/144 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Renal and urinary disorders Renal or electrolytes	1.8% 18/1016 • Number of events 25 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	2.6% 26/1016 • Number of events 38 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	2.8% 4/144 • Number of events 4 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Surgical and medical procedures Surgical procedure other than fracture repair	1.7% 17/1016 • Number of events 20 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	1.6% 16/1016 • Number of events 16 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	2.8% 4/144 • Number of events 4 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Blood and lymphatic system disorders Unknown/Other	0.00% 0/1016 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/1016 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.69% 1/144 • Number of events 1 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Cardiac disorders Unknown/Other	0.39% 4/1016 • Number of events 8 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.59% 6/1016 • Number of events 7 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.69% 1/144 • Number of events 2 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Endocrine disorders Unknown/Other	0.00% 0/1016 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.10% 1/1016 • Number of events 1 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/144 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Gastrointestinal disorders Unknown/Other	0.10% 1/1016 • Number of events 1 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.10% 1/1016 • Number of events 1 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/144 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
General disorders Unknown/Other	2.4% 24/1016 • Number of events 36 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	3.1% 31/1016 • Number of events 45 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/144 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Infections and infestations Unknown/Other	0.30% 3/1016 • Number of events 4 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	1.2% 12/1016 • Number of events 12 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/144 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Injury, poisoning and procedural complications Unknown/Other	0.20% 2/1016 • Number of events 2 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/1016 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.69% 1/144 • Number of events 1 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Musculoskeletal and connective tissue disorders Unknown/Other	0.69% 7/1016 • Number of events 7 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.30% 3/1016 • Number of events 3 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/144 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Unknown/Other	0.10% 1/1016 • Number of events 1 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/1016 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/144 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Nervous system disorders Unknown/Other	0.49% 5/1016 • Number of events 5 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.39% 4/1016 • Number of events 5 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/144 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Psychiatric disorders Unknown/Other	0.10% 1/1016 • Number of events 1 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/1016 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/144 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Renal and urinary disorders Unknown/Other	0.10% 1/1016 • Number of events 1 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.10% 1/1016 • Number of events 1 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/144 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Respiratory, thoracic and mediastinal disorders Unknown/Other	0.39% 4/1016 • Number of events 4 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.20% 2/1016 • Number of events 2 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/144 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Social circumstances Unknown/Other	0.00% 0/1016 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.10% 1/1016 • Number of events 1 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/144 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Surgical and medical procedures Unknown/Other	0.30% 3/1016 • Number of events 3 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.20% 2/1016 • Number of events 2 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/144 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.
Musculoskeletal and connective tissue disorders Muskuloskeletal	0.89% 9/1016 • Number of events 9 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	1.4% 14/1016 • Number of events 14 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.	0.00% 0/144 • Enrollment through death, withdrawal, or 18 months of follow-up Other (Not Including Serious) Adverse Events were not monitored/assessed in the study. Deaths and overnight hospitalizations of Persons Living with Dementia (PLWD) were ascertained by caregiver report. Caregiver Serious Adverse Events were not collected in the study.

Other adverse events

Adverse event data not reported

Additional Information

Jenny Summapund

University of California Los Angeles

Phone: 3233660667

Email: jsummapund@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place