Trial Outcomes & Findings for Caregiver Outcomes of Alzheimer's Disease Screening (NCT NCT03300180)

Last Updated: 2025-05-02

Results Overview

The SF-36 is a general population instrument that measures health-related quality of life, mental, physical, and social functioning. It includes one multi-item scale that assesses 8 overall health concepts. These concepts are aggregated into a Physical Component Summary and a Mental Component Summary. The eight domains are combined to reach two summary scores for Physical and Mental Health which are standardized to a mean of 50, with a score above 50 representing better than average and below 50 poorer than average function.

Recruitment status

COMPLETED

Study phase

Target enrollment

1822 participants

Primary outcome timeframe

24 month

Results posted on

2025-05-02

Participant Flow

Dyads recruited in primary care clinic or over the phone.

Consented Dyads, consisting of patient and chosen family member. Randomization was completed after patient baseline to determine screening group arm.

Participant milestones

Participant milestones
Measure	Control The patients in this group will receive no AD screening	Screening Only The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic and some information about local clinical resources for them to peruse regarding follow-up care. The patient's PCP is also be notified of the screening results via EHR message. Screening Only: The patients in this group will receive screening for AD coupled with letters sent to the dyads and the primary care PCP informing them of the results of the screening	Collaborative Dementia Care Program The patients in this group will receive screening for AD, Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic. Also, the family member will receive two follow-up phone calls. One from the COADS Study Coordinator and one from a care coordinator at the Aging Brain Care Program (ABC). This phone call will include an opportunity for the family to ask questions and a conversation about the program and diagnostic evaluation and management. Dyads have the option to refuse the follow-up visit. The patient's PCP is also be notified of the screening results via EHR message, Collaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.
Baseline STARTED	608	607	607
Baseline COMPLETED	604	601	603
Baseline NOT COMPLETED	4	6	4
6 Month Outcome STARTED	604	601	603
6 Month Outcome COMPLETED	547	533	535
6 Month Outcome NOT COMPLETED	57	68	68
12 Month Outcome STARTED	590	585	581
12 Month Outcome COMPLETED	516	514	511
12 Month Outcome NOT COMPLETED	74	71	70
18 Month Outcome Assessment STARTED	578	573	571
18 Month Outcome Assessment COMPLETED	507	503	509
18 Month Outcome Assessment NOT COMPLETED	71	70	62
24 Month Outcome Assessment STARTED	556	564	553
24 Month Outcome Assessment COMPLETED	520	520	508
24 Month Outcome Assessment NOT COMPLETED	36	44	45

Reasons for withdrawal

Reasons for withdrawal
Measure	Control The patients in this group will receive no AD screening	Screening Only The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic and some information about local clinical resources for them to peruse regarding follow-up care. The patient's PCP is also be notified of the screening results via EHR message. Screening Only: The patients in this group will receive screening for AD coupled with letters sent to the dyads and the primary care PCP informing them of the results of the screening	Collaborative Dementia Care Program The patients in this group will receive screening for AD, Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic. Also, the family member will receive two follow-up phone calls. One from the COADS Study Coordinator and one from a care coordinator at the Aging Brain Care Program (ABC). This phone call will include an opportunity for the family to ask questions and a conversation about the program and diagnostic evaluation and management. Dyads have the option to refuse the follow-up visit. The patient's PCP is also be notified of the screening results via EHR message, Collaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.
Baseline Withdrawal by Subject	4	6	4
6 Month Outcome Withdrawal by Subject	12	12	19
6 Month Outcome Death	2	4	3
6 Month Outcome Missed Assessment	43	52	46
12 Month Outcome Withdrawal by Subject	3	6	6
12 Month Outcome Death	9	6	6
12 Month Outcome Missed Assessment	62	59	58
18 Month Outcome Assessment Withdrawal by Subject	14	4	13
18 Month Outcome Assessment Death	8	5	5
18 Month Outcome Assessment Missed Assessment	49	61	44
24 Month Outcome Assessment Withdrawal by Subject	6	10	4
24 Month Outcome Assessment Death	13	13	3
24 Month Outcome Assessment Missed Assessment	17	21	38

Baseline Characteristics

Patient Age,

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=1208 Participants The patients in this group will receive no AD screening	Screening Only n=1202 Participants The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic and some information about local clinical resources for them to peruse regarding follow-up care. The patient's PCP is also be notified of the screening results via EHR message. Screening Only: The patients in this group will receive screening for AD coupled with letters sent to the dyads and the primary care PCP informing them of the results of the screening	Collaborative Dementia Care Program n=1206 Participants The patients in this group will receive screening for AD, Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic. Also, the family member will receive two follow-up phone calls. One from the COADS Study Coordinator and one from a care coordinator at the Aging Brain Care Program (ABC). This phone call will include an opportunity for the family to ask questions and a conversation about the program and diagnostic evaluation and management. Dyads have the option to refuse the follow-up visit. The patient's PCP is also be notified of the screening results via EHR message, Collaborative Dementia Care Program: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.	Total n=3616 Participants Total of all reporting groups
Age, Continuous	63.8 in years STANDARD_DEVIATION 13.0 • n=604 Participants • Family Member Age	64.4 in years STANDARD_DEVIATION 12.7 • n=601 Participants • Family Member Age	64.4 in years STANDARD_DEVIATION 13.1 • n=603 Participants • Family Member Age	64.2 in years STANDARD_DEVIATION 12.9 • n=1808 Participants • Family Member Age
Sex: Female, Male Female	406 Participants n=604 Participants • Family Member Sex- excluding refused/withdrawn	407 Participants n=601 Participants • Family Member Sex- excluding refused/withdrawn	411 Participants n=602 Participants • Family Member Sex- excluding refused/withdrawn	1224 Participants n=1807 Participants • Family Member Sex- excluding refused/withdrawn
Sex: Female, Male Male	198 Participants n=604 Participants • Family Member Sex- excluding refused/withdrawn	194 Participants n=601 Participants • Family Member Sex- excluding refused/withdrawn	191 Participants n=602 Participants • Family Member Sex- excluding refused/withdrawn	583 Participants n=1807 Participants • Family Member Sex- excluding refused/withdrawn
Race/Ethnicity, Customized Asian	5 Participants n=604 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn	9 Participants n=601 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn	3 Participants n=603 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn	17 Participants n=1808 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn
Race/Ethnicity, Customized Black or African American	92 Participants n=604 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn	79 Participants n=601 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn	71 Participants n=603 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn	242 Participants n=1808 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn
Race/Ethnicity, Customized White	504 Participants n=604 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn	501 Participants n=601 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn	518 Participants n=603 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn	1523 Participants n=1808 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn
Race/Ethnicity, Customized Other	2 Participants n=604 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn	8 Participants n=601 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn	9 Participants n=603 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn	19 Participants n=1808 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn
Race/Ethnicity, Customized Hispanic ethnicity, self-reported	5 Participants n=604 Participants • Patient Race/Ethnicity	5 Participants n=601 Participants • Patient Race/Ethnicity	10 Participants n=603 Participants • Patient Race/Ethnicity	20 Participants n=1808 Participants • Patient Race/Ethnicity
Race/Ethnicity, Customized Hispanic ethnicity	3 Participants n=604 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn	4 Participants n=601 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn	7 Participants n=603 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn	14 Participants n=1808 Participants • Family Member Race/Ethnicity-excluding missing/withdrawn
Severe Depression	8 Participants n=604 Participants • Family member -Severe Depression is defined as PHQ-9 score of ≥15- excluding missing/withdrawn	9 Participants n=601 Participants • Family member -Severe Depression is defined as PHQ-9 score of ≥15- excluding missing/withdrawn	7 Participants n=603 Participants • Family member -Severe Depression is defined as PHQ-9 score of ≥15- excluding missing/withdrawn	24 Participants n=1808 Participants • Family member -Severe Depression is defined as PHQ-9 score of ≥15- excluding missing/withdrawn
Severe Anxiety	6 Participants n=604 Participants • Family Member - Severe Anxiety is defined as GAD-7 score of ≥15- excluding missing/withdrawn	5 Participants n=601 Participants • Family Member - Severe Anxiety is defined as GAD-7 score of ≥15- excluding missing/withdrawn	3 Participants n=603 Participants • Family Member - Severe Anxiety is defined as GAD-7 score of ≥15- excluding missing/withdrawn	14 Participants n=1808 Participants • Family Member - Severe Anxiety is defined as GAD-7 score of ≥15- excluding missing/withdrawn
Oberst Scale, time	21.0 units on a scale STANDARD_DEVIATION 7.3 • n=604 Participants • Family member- Oberst Scale, time- excluding missing/withdrawn	21.0 units on a scale STANDARD_DEVIATION 7.2 • n=601 Participants • Family member- Oberst Scale, time- excluding missing/withdrawn	20.7 units on a scale STANDARD_DEVIATION 7.0 • n=603 Participants • Family member- Oberst Scale, time- excluding missing/withdrawn	20.9 units on a scale STANDARD_DEVIATION 7.1 • n=1808 Participants • Family member- Oberst Scale, time- excluding missing/withdrawn
Oberst Caregiving Burden Scale, difficulty subscale	15.6 units on a scale STANDARD_DEVIATION 2.8 • n=604 Participants • Family member- Oberst Scale, difficulty- excluding missing/withdrawn	15.5 units on a scale STANDARD_DEVIATION 1.8 • n=601 Participants • Family member- Oberst Scale, difficulty- excluding missing/withdrawn	15.6 units on a scale STANDARD_DEVIATION 1.8 • n=603 Participants • Family member- Oberst Scale, difficulty- excluding missing/withdrawn	15.5 units on a scale STANDARD_DEVIATION 2.1 • n=1808 Participants • Family member- Oberst Scale, difficulty- excluding missing/withdrawn

PRIMARY outcome

Timeframe: 24 month

Population: Patient \& Family Member Outcome Results of SF-36 at 24 months

Outcome measures

Outcome measures
Measure	Control n=1025 Participants The patients in this group will receive no AD screening	Screening Only n=1023 Participants Screening Only: The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic and some information about local clinical resources for them to peruse regarding follow-up care. The patient's PCP is also be notified of the screening results via EHR message.	Screen Plus n=1004 Participants Collaborative Care Program: The patients in this group will receive screening for AD, Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic. Also, the family member will receive two follow-up phone calls. One from the COADS Study Coordinator and one from a care coordinator at the Aging Brain Care Program (ABC). This phone call will include an opportunity for the family to ask questions and a conversation about the program and diagnostic evaluation and management. Dyads have the option to refuse the follow-up visit. The patient's PCP is also be notified of the screening results via EHR message,
Short Form Health Survey (SF-36) Family Member- Mental Health Component	54.5 score on a scale Standard Deviation 7.2	55.3 score on a scale Standard Deviation 6.7	54.7 score on a scale Standard Deviation 7.5
Short Form Health Survey (SF-36) Family Member- Physical Health Component	48.4 score on a scale Standard Deviation 9.8	47.8 score on a scale Standard Deviation 10.2	48.8 score on a scale Standard Deviation 9.4
Short Form Health Survey (SF-36) Patient-Physical Health Component	44.7 score on a scale Standard Deviation 11.1	44.8 score on a scale Standard Deviation 11.2	44.4 score on a scale Standard Deviation 11.1
Short Form Health Survey (SF-36) Patient-Mental Health Component	54.9 score on a scale Standard Deviation 7.5	55.3 score on a scale Standard Deviation 7.4	55.3 score on a scale Standard Deviation 7.6

SECONDARY outcome

Timeframe: PHQ-9 results for patient & family member at 24 months

Population: PHQ-9 results for patient \& family member at 24 months

The investigators will use the Patient Health Questionnaire-9 (PHQ-9) to determine the impact of AD screening on caregivers and patients mood. The PHQ-9 is a nine-item depression scale with a total score from 0 to 27 with higher scores indicating greater depression severity. Multi-level mixed effects models will be used to examine differences in PHQ-9 scores for both patients and family members using dyadic analytic approaches. For this aim, we will compare family members in the two screening groups (Screening Only and Screening Plus) to those in the no screening (Control) group. Repeated PHQ-9 scores from both patients and family members will be included as the outcome variables with participant type (patient or family member), group (Screening Only and Screening Plus versus Control), time, and interaction between groups and time as independent variables.

Outcome measures

Outcome measures
Measure	Control n=1026 Participants The patients in this group will receive no AD screening	Screening Only n=1023 Participants Screening Only: The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic and some information about local clinical resources for them to peruse regarding follow-up care. The patient's PCP is also be notified of the screening results via EHR message.	Screen Plus n=1006 Participants Collaborative Care Program: The patients in this group will receive screening for AD, Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic. Also, the family member will receive two follow-up phone calls. One from the COADS Study Coordinator and one from a care coordinator at the Aging Brain Care Program (ABC). This phone call will include an opportunity for the family to ask questions and a conversation about the program and diagnostic evaluation and management. Dyads have the option to refuse the follow-up visit. The patient's PCP is also be notified of the screening results via EHR message,
Depressive Symptoms Patient 24 Month	2.8 score on a scale Standard Deviation 3.6	2.6 score on a scale Standard Deviation 3.8	2.9 score on a scale Standard Deviation 3.9
Depressive Symptoms Family member 24 Month	2.4 score on a scale Standard Deviation 3.4	2.3 score on a scale Standard Deviation 2.9	2.2 score on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: 24 month GAD-7 scores for Family members & Patients

Population: 24 month GAD-7 scores for Family members \& Patients

The investigators will use the Generalized Anxiety Disorder Scale (GAD-7) to determine the impact of AD screening on caregivers and patients anxiety. The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21 with higher scores indicating greater anxiety severity. Multi-level mixed effects models will be used to examine differences in GAD-7 scores for both patients and family members using dyadic analytic approaches. For this aim, we will compare family members in the two screening groups (Screening Only and Screening Plus) to those in the no screening (Control) group. Repeated GAD-7 scores from both patients and family members will be included as the outcome variables with participant type (patient or family member), group (Screening Only and Screening Plus versus Control), time, and interaction between groups and time as independent variables.

Outcome measures

Outcome measures
Measure	Control n=1026 Participants The patients in this group will receive no AD screening	Screening Only n=1023 Participants Screening Only: The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic and some information about local clinical resources for them to peruse regarding follow-up care. The patient's PCP is also be notified of the screening results via EHR message.	Screen Plus n=1006 Participants Collaborative Care Program: The patients in this group will receive screening for AD, Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic. Also, the family member will receive two follow-up phone calls. One from the COADS Study Coordinator and one from a care coordinator at the Aging Brain Care Program (ABC). This phone call will include an opportunity for the family to ask questions and a conversation about the program and diagnostic evaluation and management. Dyads have the option to refuse the follow-up visit. The patient's PCP is also be notified of the screening results via EHR message,
Anxiety Symptoms Family member	1.8 score on a scale Standard Deviation 3.0	1.6 score on a scale Standard Deviation 2.5	1.7 score on a scale Standard Deviation 3.0
Anxiety Symptoms Patient	1.7 score on a scale Standard Deviation 2.6	1.8 score on a scale Standard Deviation 3.3	1.8 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: 24 month

The Preparedness for Caregiving Scale consists of eight items that asks family members how well prepared they believe they are for multiple domains of caregiving. Responses are rated on a 5-point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. The higher the score the more prepared the caregiver feels for caregiving; the lower the score, the less prepared the caregiver feels. Multi-level mixed effects models will be used to examine differences in Preparedness for Caregiving Scale scores for family members using dyadic analytic approaches. For this aim, we will compare family members in the two screening groups (Screening Only and Screening Plus) to those in the no screening (Control) group. Repeated Preparedness for Care

Outcome measures

Outcome measures
Measure	Control n=505 Participants The patients in this group will receive no AD screening	Screening Only n=504 Participants Screening Only: The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic and some information about local clinical resources for them to peruse regarding follow-up care. The patient's PCP is also be notified of the screening results via EHR message.	Screen Plus n=498 Participants Collaborative Care Program: The patients in this group will receive screening for AD, Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic. Also, the family member will receive two follow-up phone calls. One from the COADS Study Coordinator and one from a care coordinator at the Aging Brain Care Program (ABC). This phone call will include an opportunity for the family to ask questions and a conversation about the program and diagnostic evaluation and management. Dyads have the option to refuse the follow-up visit. The patient's PCP is also be notified of the screening results via EHR message,
Caregiving Preparedness	3.0 score on a scale Standard Deviation 0.7	2.9 score on a scale Standard Deviation 0.6	2.9 score on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 24 month result for Family member

The investigators will use the Revised Scale for Caregiving Self Efficacy to measure the impact of AD screening on caregiver self-efficacy. Respondents rate their degree of self-efficacy on a scale from 0 (absolutely incapable) to 100 (fully capable).

Outcome measures

Outcome measures
Measure	Control n=501 Participants The patients in this group will receive no AD screening	Screening Only n=504 Participants Screening Only: The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic and some information about local clinical resources for them to peruse regarding follow-up care. The patient's PCP is also be notified of the screening results via EHR message.	Screen Plus n=497 Participants Collaborative Care Program: The patients in this group will receive screening for AD, Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic. Also, the family member will receive two follow-up phone calls. One from the COADS Study Coordinator and one from a care coordinator at the Aging Brain Care Program (ABC). This phone call will include an opportunity for the family to ask questions and a conversation about the program and diagnostic evaluation and management. Dyads have the option to refuse the follow-up visit. The patient's PCP is also be notified of the screening results via EHR message,
Caregiving Self Efficacy	79.1 score on a scale Standard Deviation 15.5	79.3 score on a scale Standard Deviation 14.0	79.6 score on a scale Standard Deviation 15.0

Adverse Events

Control Patients

Serious events: 79 serious events

Other events: 41 other events

Deaths: 24 deaths

Control Family Member

Serious events: 101 serious events

Other events: 34 other events

Deaths: 8 deaths

Screening Only Patient

Serious events: 69 serious events

Other events: 42 other events

Deaths: 19 deaths

Screening Only Family Member.

Serious events: 82 serious events

Other events: 19 other events

Deaths: 9 deaths

Collaborative Dementia Care Program Patients

Serious events: 85 serious events

Other events: 43 other events

Deaths: 12 deaths

Collaborative Dementia Care Program Family Member

Serious events: 96 serious events

Other events: 35 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Control Patients n=608 participants at risk The patients in this group will receive no AD screening	Control Family Member n=608 participants at risk Represents the Family member of the Control Group patient. The patients in this group will receive no AD screening	Screening Only Patient n=607 participants at risk The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic and some information about local clinical resources for them to peruse regarding follow-up care. The patient's PCP is also be notified of the screening results via EHR message.	Screening Only Family Member. n=607 participants at risk Represents the Family member of the Screening only group. The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic and some information about local clinical resources for them to peruse regarding follow-up care. The patient's PCP is also be notified of the screening results via EHR message.	Collaborative Dementia Care Program Patients n=607 participants at risk The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic. Also, the family member will receive two follow-up phone calls. One from the COADS Study Coordinator and one from a care coordinator at the Aging Brain Care Program (ABC). This phone call will include an opportunity for the family to ask questions and a conversation about the program and diagnostic evaluation and management. Dyads have the option to refuse the follow-up visit. The patient's PCP is also be notified of the screening results via EHR message,	Collaborative Dementia Care Program Family Member n=607 participants at risk Represents the Family member of the Collaborative Dementia Care Program. The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic. Also, the family member will receive two follow-up phone calls. One from the COADS Study Coordinator and one from a care coordinator at the Aging Brain Care Program (ABC). This phone call will include an opportunity for the family to ask questions and a conversation about the program and diagnostic evaluation and management. Dyads have the option to refuse the follow-up visit. The patient's PCP is also be notified of the screening results via EHR message,
General disorders Inpatient Hospitalization or prolongation of existing hospitalization	13.0% 79/608 • Number of events 131 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.	16.6% 101/608 • Number of events 159 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.	11.4% 69/607 • Number of events 125 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.	13.5% 82/607 • Number of events 121 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.	14.0% 85/607 • Number of events 134 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.	15.8% 96/607 • Number of events 134 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.

Other adverse events

Other adverse events
Measure	Control Patients n=608 participants at risk The patients in this group will receive no AD screening	Control Family Member n=608 participants at risk Represents the Family member of the Control Group patient. The patients in this group will receive no AD screening	Screening Only Patient n=607 participants at risk The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic and some information about local clinical resources for them to peruse regarding follow-up care. The patient's PCP is also be notified of the screening results via EHR message.	Screening Only Family Member. n=607 participants at risk Represents the Family member of the Screening only group. The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic and some information about local clinical resources for them to peruse regarding follow-up care. The patient's PCP is also be notified of the screening results via EHR message.	Collaborative Dementia Care Program Patients n=607 participants at risk The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic. Also, the family member will receive two follow-up phone calls. One from the COADS Study Coordinator and one from a care coordinator at the Aging Brain Care Program (ABC). This phone call will include an opportunity for the family to ask questions and a conversation about the program and diagnostic evaluation and management. Dyads have the option to refuse the follow-up visit. The patient's PCP is also be notified of the screening results via EHR message,	Collaborative Dementia Care Program Family Member n=607 participants at risk Represents the Family member of the Collaborative Dementia Care Program. The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic. Also, the family member will receive two follow-up phone calls. One from the COADS Study Coordinator and one from a care coordinator at the Aging Brain Care Program (ABC). This phone call will include an opportunity for the family to ask questions and a conversation about the program and diagnostic evaluation and management. Dyads have the option to refuse the follow-up visit. The patient's PCP is also be notified of the screening results via EHR message,
Psychiatric disorders Severe Depression Post- Baseline as measured by PHQ-9 (≥15)	4.3% 26/608 • Number of events 48 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.	3.0% 18/608 • Number of events 23 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.	4.0% 24/607 • Number of events 36 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.	1.8% 11/607 • Number of events 15 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.	4.6% 28/607 • Number of events 43 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.	3.1% 19/607 • Number of events 24 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.
Psychiatric disorders Severe Anxiety Post-Baseline as measured by GAD-7 (≥15)	2.5% 15/608 • Number of events 19 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.	2.6% 16/608 • Number of events 20 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.	3.0% 18/607 • Number of events 28 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.	1.3% 8/607 • Number of events 10 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.	2.5% 15/607 • Number of events 19 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.	2.6% 16/607 • Number of events 19 • Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score. All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined. Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline. Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.

Additional Information

Nicole R. Fowler, PhD, MHSA; Associate Professor of Medicine

Indiana University School of Medicine; Indiana University Center for Aging Research; Regenstrief Institute, Inc.

Phone: 317-274-9021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place