Trial Outcomes & Findings for Indiana Palliative Excellence in Alzheimer's Care Efforts (NCT NCT03773757)
NCT ID: NCT03773757
Last Updated: 2024-08-27
Results Overview
The Neuropsychiatric Inventory Questionnaire measures the presence and severity of 12 neuropsychiatric symptoms in the person with dementia (PWD) in the past month per caregiver report. Each symptom reported as present is scored on a scale of 1-3 with higher scores indicating more severity of the symptom: mild, moderate, or severe. The NPI-Q Patient Symptom and Severity total score is constructed by summing the value of each presenting symptom's severity and ranges from 0-36 with higher scores indicating more severe patient neuropsychiatric symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
402 participants
Primary outcome timeframe
0-24 months
Results posted on
2024-08-27
Participant Flow
Recruitment started on 3/14/2019 and ended on 12/21/2020. Recruitment locations included two health systems and personal referrals at a caregiver symposium within a 50-mile radius of Indianapolis. Initially, recruitment included an in-person approach in the medical clinic followed by in-person enrollment in the caregiver's home. After the Institutional Review Board (IRB) approved verbal consent 3/17/2020, all recruitment took place over the phone.
Data values reported in the Participant Flow represent individual participants.
Participant milestones
| Measure |
IN-PEACE Dementia Care Coordination
IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.
IN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.
|
Usual Care
The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study.
|
|---|---|---|
|
Overall Study
STARTED
|
198
|
204
|
|
Overall Study
COMPLETED
|
196
|
200
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
IN-PEACE Dementia Care Coordination
IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.
IN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.
|
Usual Care
The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
Baseline Characteristics
The MoCA was administered with person with dementia (PWD) if caregiver gave permission. In some cases, the PWD was unable to take the test. When the IRB approved protocol amendment 12 to recruit fully remote and with verbal consent only, the MoCA was no longer administered during baseline.The total MoCAs administered for the study was 32.
Baseline characteristics by cohort
| Measure |
IN-PEACE Dementia Care Coordination
n=99 Dyad: Patient and Caregiver
IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.
IN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.
|
Usual Care
n=102 Dyad: Patient and Caregiver
The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study.
|
Total
n=201 Dyad: Patient and Caregiver
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Patient Participants
|
83.7 years
STANDARD_DEVIATION 7.7 • n=99 Participants
|
83.4 years
STANDARD_DEVIATION 8.1 • n=102 Participants
|
83.6 years
STANDARD_DEVIATION 7.9 • n=201 Participants
|
|
Age, Continuous
Caregiver Participants
|
60.8 years
STANDARD_DEVIATION 12.3 • n=99 Participants
|
60.2 years
STANDARD_DEVIATION 10.1 • n=102 Participants
|
60.5 years
STANDARD_DEVIATION 11.2 • n=201 Participants
|
|
Sex: Female, Male
Patient Participants · Female
|
67 Participants
n=99 Participants
|
69 Participants
n=102 Participants
|
136 Participants
n=201 Participants
|
|
Sex: Female, Male
Patient Participants · Male
|
32 Participants
n=99 Participants
|
33 Participants
n=102 Participants
|
65 Participants
n=201 Participants
|
|
Sex: Female, Male
Caregiver Participants · Female
|
82 Participants
n=99 Participants
|
81 Participants
n=102 Participants
|
163 Participants
n=201 Participants
|
|
Sex: Female, Male
Caregiver Participants · Male
|
17 Participants
n=99 Participants
|
21 Participants
n=102 Participants
|
38 Participants
n=201 Participants
|
|
Ethnicity (NIH/OMB)
Patient Participants · Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=102 Participants
|
5 Participants
n=201 Participants
|
|
Ethnicity (NIH/OMB)
Patient Participants · Not Hispanic or Latino
|
94 Participants
n=99 Participants
|
95 Participants
n=102 Participants
|
189 Participants
n=201 Participants
|
|
Ethnicity (NIH/OMB)
Patient Participants · Unknown or Not Reported
|
3 Participants
n=99 Participants
|
4 Participants
n=102 Participants
|
7 Participants
n=201 Participants
|
|
Ethnicity (NIH/OMB)
Caregiver Participants · Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=102 Participants
|
5 Participants
n=201 Participants
|
|
Ethnicity (NIH/OMB)
Caregiver Participants · Not Hispanic or Latino
|
94 Participants
n=99 Participants
|
94 Participants
n=102 Participants
|
188 Participants
n=201 Participants
|
|
Ethnicity (NIH/OMB)
Caregiver Participants · Unknown or Not Reported
|
3 Participants
n=99 Participants
|
5 Participants
n=102 Participants
|
8 Participants
n=201 Participants
|
|
Race/Ethnicity, Customized
African American: PWD
|
44 Participants
n=99 Participants
|
43 Participants
n=102 Participants
|
87 Participants
n=201 Participants
|
|
Race/Ethnicity, Customized
African American: Caregiver
|
43 Participants
n=99 Participants
|
46 Participants
n=102 Participants
|
89 Participants
n=201 Participants
|
|
Race/Ethnicity, Customized
White: PWD
|
48 Participants
n=99 Participants
|
53 Participants
n=102 Participants
|
101 Participants
n=201 Participants
|
|
Race/Ethnicity, Customized
White: Caregiver
|
49 Participants
n=99 Participants
|
52 Participants
n=102 Participants
|
101 Participants
n=201 Participants
|
|
Race/Ethnicity, Customized
Others: PWD
|
3 Participants
n=99 Participants
|
4 Participants
n=102 Participants
|
7 Participants
n=201 Participants
|
|
Race/Ethnicity, Customized
Others: Caregiver
|
3 Participants
n=99 Participants
|
2 Participants
n=102 Participants
|
5 Participants
n=201 Participants
|
|
Race/Ethnicity, Customized
Refused to Answer: PWD
|
4 Participants
n=99 Participants
|
2 Participants
n=102 Participants
|
6 Participants
n=201 Participants
|
|
Race/Ethnicity, Customized
Refused to Answer: Caregiver
|
4 Participants
n=99 Participants
|
2 Participants
n=102 Participants
|
6 Participants
n=201 Participants
|
|
Region of Enrollment
United States
|
99 Dyad: Patient and Caregiver
n=99 Dyad: Patient and Caregiver
|
102 Dyad: Patient and Caregiver
n=102 Dyad: Patient and Caregiver
|
201 Dyad: Patient and Caregiver
n=201 Dyad: Patient and Caregiver
|
|
Education
PWD · High School or Less
|
53 Participants
n=99 Participants
|
53 Participants
n=102 Participants
|
106 Participants
n=201 Participants
|
|
Education
PWD · Some college or college degree
|
30 Participants
n=99 Participants
|
29 Participants
n=102 Participants
|
59 Participants
n=201 Participants
|
|
Education
PWD · Post graduate
|
16 Participants
n=99 Participants
|
19 Participants
n=102 Participants
|
35 Participants
n=201 Participants
|
|
Education
PWD · did not answer
|
0 Participants
n=99 Participants
|
1 Participants
n=102 Participants
|
1 Participants
n=201 Participants
|
|
Education
Caregiver · High School or Less
|
13 Participants
n=99 Participants
|
18 Participants
n=102 Participants
|
31 Participants
n=201 Participants
|
|
Education
Caregiver · Some college or college degree
|
60 Participants
n=99 Participants
|
54 Participants
n=102 Participants
|
114 Participants
n=201 Participants
|
|
Education
Caregiver · Post graduate
|
26 Participants
n=99 Participants
|
29 Participants
n=102 Participants
|
55 Participants
n=201 Participants
|
|
Education
Caregiver · did not answer
|
0 Participants
n=99 Participants
|
1 Participants
n=102 Participants
|
1 Participants
n=201 Participants
|
|
Marital Status
PWD · Divorced/Separated
|
25 Participants
n=99 Participants
|
12 Participants
n=102 Participants
|
37 Participants
n=201 Participants
|
|
Marital Status
PWD · Married/Living together
|
32 Participants
n=99 Participants
|
30 Participants
n=102 Participants
|
62 Participants
n=201 Participants
|
|
Marital Status
PWD · Never Married
|
6 Participants
n=99 Participants
|
8 Participants
n=102 Participants
|
14 Participants
n=201 Participants
|
|
Marital Status
PWD · Widowed
|
36 Participants
n=99 Participants
|
52 Participants
n=102 Participants
|
88 Participants
n=201 Participants
|
|
Marital Status
Caregiver · Divorced/Separated
|
13 Participants
n=99 Participants
|
15 Participants
n=102 Participants
|
28 Participants
n=201 Participants
|
|
Marital Status
Caregiver · Married/Living together
|
66 Participants
n=99 Participants
|
71 Participants
n=102 Participants
|
137 Participants
n=201 Participants
|
|
Marital Status
Caregiver · Never Married
|
19 Participants
n=99 Participants
|
13 Participants
n=102 Participants
|
32 Participants
n=201 Participants
|
|
Marital Status
Caregiver · Widowed
|
1 Participants
n=99 Participants
|
3 Participants
n=102 Participants
|
4 Participants
n=201 Participants
|
|
Income
PWD : Under $24,999 · Yes
|
46 Participants
n=99 Participants
|
37 Participants
n=102 Participants
|
83 Participants
n=201 Participants
|
|
Income
PWD : Under $24,999 · No
|
53 Participants
n=99 Participants
|
65 Participants
n=102 Participants
|
118 Participants
n=201 Participants
|
|
Income
PWD : $25,000 - 49,999 · Yes
|
12 Participants
n=99 Participants
|
21 Participants
n=102 Participants
|
33 Participants
n=201 Participants
|
|
Income
PWD : $25,000 - 49,999 · No
|
87 Participants
n=99 Participants
|
81 Participants
n=102 Participants
|
168 Participants
n=201 Participants
|
|
Income
PWD : $50,000 - 99,999 · Yes
|
6 Participants
n=99 Participants
|
7 Participants
n=102 Participants
|
13 Participants
n=201 Participants
|
|
Income
PWD : $50,000 - 99,999 · No
|
93 Participants
n=99 Participants
|
95 Participants
n=102 Participants
|
188 Participants
n=201 Participants
|
|
Income
PWD : $100,000 and over · Yes
|
3 Participants
n=99 Participants
|
5 Participants
n=102 Participants
|
8 Participants
n=201 Participants
|
|
Income
PWD : $100,000 and over · No
|
96 Participants
n=99 Participants
|
97 Participants
n=102 Participants
|
193 Participants
n=201 Participants
|
|
Income
PWD : Do not wish to answer · Yes
|
10 Participants
n=99 Participants
|
14 Participants
n=102 Participants
|
24 Participants
n=201 Participants
|
|
Income
PWD : Do not wish to answer · No
|
89 Participants
n=99 Participants
|
88 Participants
n=102 Participants
|
177 Participants
n=201 Participants
|
|
Income
PWD : Caregiver is the spouse · Yes
|
20 Participants
n=99 Participants
|
18 Participants
n=102 Participants
|
38 Participants
n=201 Participants
|
|
Income
PWD : Caregiver is the spouse · No
|
79 Participants
n=99 Participants
|
84 Participants
n=102 Participants
|
163 Participants
n=201 Participants
|
|
Income
Caregiver : Under $24,999 · Yes
|
13 Participants
n=99 Participants
|
13 Participants
n=102 Participants
|
26 Participants
n=201 Participants
|
|
Income
Caregiver : Under $24,999 · No
|
86 Participants
n=99 Participants
|
89 Participants
n=102 Participants
|
175 Participants
n=201 Participants
|
|
Income
Caregiver : $25,000 - 49,999 · Yes
|
26 Participants
n=99 Participants
|
29 Participants
n=102 Participants
|
55 Participants
n=201 Participants
|
|
Income
Caregiver : $25,000 - 49,999 · No
|
73 Participants
n=99 Participants
|
73 Participants
n=102 Participants
|
146 Participants
n=201 Participants
|
|
Income
Caregiver : $50,000 - 99,999 · Yes
|
23 Participants
n=99 Participants
|
21 Participants
n=102 Participants
|
44 Participants
n=201 Participants
|
|
Income
Caregiver : $50,000 - 99,999 · No
|
76 Participants
n=99 Participants
|
81 Participants
n=102 Participants
|
157 Participants
n=201 Participants
|
|
Income
Caregiver : $100,000 and over · Yes
|
24 Participants
n=99 Participants
|
29 Participants
n=102 Participants
|
53 Participants
n=201 Participants
|
|
Income
Caregiver : $100,000 and over · No
|
75 Participants
n=99 Participants
|
73 Participants
n=102 Participants
|
148 Participants
n=201 Participants
|
|
Income
Caregiver : Do not wish to answer · Yes
|
13 Participants
n=99 Participants
|
10 Participants
n=102 Participants
|
23 Participants
n=201 Participants
|
|
Income
Caregiver : Do not wish to answer · No
|
86 Participants
n=99 Participants
|
92 Participants
n=102 Participants
|
178 Participants
n=201 Participants
|
|
Caregiver Relationship to Patient
Spouse/Partner
|
22 Participants
n=99 Participants
|
22 Participants
n=102 Participants
|
44 Participants
n=201 Participants
|
|
Caregiver Relationship to Patient
Daughter/Son/Daughter-in-Law/Son-in-Law
|
68 Participants
n=99 Participants
|
67 Participants
n=102 Participants
|
135 Participants
n=201 Participants
|
|
Caregiver Relationship to Patient
Grandchild
|
1 Participants
n=99 Participants
|
2 Participants
n=102 Participants
|
3 Participants
n=201 Participants
|
|
Caregiver Relationship to Patient
Other relationship
|
8 Participants
n=99 Participants
|
11 Participants
n=102 Participants
|
19 Participants
n=201 Participants
|
|
Patient Institution
Eskenazi
|
56 Participants
n=99 Participants
|
65 Participants
n=102 Participants
|
121 Participants
n=201 Participants
|
|
Patient Institution
IU Health
|
42 Participants
n=99 Participants
|
37 Participants
n=102 Participants
|
79 Participants
n=201 Participants
|
|
Patient Institution
St. Vincent
|
1 Participants
n=99 Participants
|
0 Participants
n=102 Participants
|
1 Participants
n=201 Participants
|
|
Functional Assessment Staging Tool for Dementia (FAST)
Moderate (FAST=5)
|
4 participants
n=99 Participants
|
4 participants
n=102 Participants
|
8 participants
n=201 Participants
|
|
Functional Assessment Staging Tool for Dementia (FAST)
Severe (FAST=6-7)
|
95 participants
n=99 Participants
|
98 participants
n=102 Participants
|
193 participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
Asthma, emphysema, or chronic bronchitis · Yes
|
18 Participants
n=99 Participants
|
11 Participants
n=102 Participants
|
29 Participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
Asthma, emphysema, or chronic bronchitis · No
|
81 Participants
n=99 Participants
|
91 Participants
n=102 Participants
|
172 Participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
High blood pressure or hypertension · Yes
|
71 Participants
n=99 Participants
|
73 Participants
n=102 Participants
|
144 Participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
High blood pressure or hypertension · No
|
28 Participants
n=99 Participants
|
29 Participants
n=102 Participants
|
57 Participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
High blood sugar or diabetes · Yes
|
25 Participants
n=99 Participants
|
29 Participants
n=102 Participants
|
54 Participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
High blood sugar or diabetes · No
|
74 Participants
n=99 Participants
|
73 Participants
n=102 Participants
|
147 Participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
Arthritis or rheumatism (inflammation of the joints) · Yes
|
54 Participants
n=99 Participants
|
59 Participants
n=102 Participants
|
113 Participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
Arthritis or rheumatism (inflammation of the joints) · No
|
45 Participants
n=99 Participants
|
43 Participants
n=102 Participants
|
88 Participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
Angina, heart failure, or other types of heart disease · Yes
|
33 Participants
n=99 Participants
|
36 Participants
n=102 Participants
|
69 Participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
Angina, heart failure, or other types of heart disease · No
|
66 Participants
n=99 Participants
|
66 Participants
n=102 Participants
|
132 Participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
Stroke, seizures, Parkinson's disease, or another neurological condition · Yes
|
25 Participants
n=99 Participants
|
37 Participants
n=102 Participants
|
62 Participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
Stroke, seizures, Parkinson's disease, or another neurological condition · No
|
74 Participants
n=99 Participants
|
65 Participants
n=102 Participants
|
139 Participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
Liver disease · Yes
|
2 Participants
n=99 Participants
|
2 Participants
n=102 Participants
|
4 Participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
Liver disease · No
|
97 Participants
n=99 Participants
|
100 Participants
n=102 Participants
|
197 Participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
Kidney or renal disease · Yes
|
16 Participants
n=99 Participants
|
18 Participants
n=102 Participants
|
34 Participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
Kidney or renal disease · No
|
83 Participants
n=99 Participants
|
84 Participants
n=102 Participants
|
167 Participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
Cancer · Yes
|
10 Participants
n=99 Participants
|
10 Participants
n=102 Participants
|
20 Participants
n=201 Participants
|
|
Patient Medical Conditions (Comorbidities)
Cancer · No
|
89 Participants
n=99 Participants
|
92 Participants
n=102 Participants
|
181 Participants
n=201 Participants
|
|
Montreal Cognitive Assessment (MoCA)
|
10.5 score on a scale
STANDARD_DEVIATION 4.2 • n=16 Participants • The MoCA was administered with person with dementia (PWD) if caregiver gave permission. In some cases, the PWD was unable to take the test. When the IRB approved protocol amendment 12 to recruit fully remote and with verbal consent only, the MoCA was no longer administered during baseline.The total MoCAs administered for the study was 32.
|
11.4 score on a scale
STANDARD_DEVIATION 4.5 • n=16 Participants • The MoCA was administered with person with dementia (PWD) if caregiver gave permission. In some cases, the PWD was unable to take the test. When the IRB approved protocol amendment 12 to recruit fully remote and with verbal consent only, the MoCA was no longer administered during baseline.The total MoCAs administered for the study was 32.
|
10.9 score on a scale
STANDARD_DEVIATION 4.3 • n=32 Participants • The MoCA was administered with person with dementia (PWD) if caregiver gave permission. In some cases, the PWD was unable to take the test. When the IRB approved protocol amendment 12 to recruit fully remote and with verbal consent only, the MoCA was no longer administered during baseline.The total MoCAs administered for the study was 32.
|
|
Neuropsychiatric Inventory Questionnaire (NPI-Q: PWD)
|
9.9 score on a scale
STANDARD_DEVIATION 6.7 • n=99 Participants
|
9.4 score on a scale
STANDARD_DEVIATION 6.4 • n=102 Participants
|
9.7 score on a scale
STANDARD_DEVIATION 6.5 • n=201 Participants
|
|
Symptom Measures in End-of-Life Dementia (SM-EOLD)
|
29.8 score on a scale
STANDARD_DEVIATION 9 • n=99 Participants
|
28.8 score on a scale
STANDARD_DEVIATION 8.8 • n=102 Participants
|
29.3 score on a scale
STANDARD_DEVIATION 8.9 • n=201 Participants
|
|
Physical Self-Maintenance Scale/Activities of Daily Living (PSMS/ADLs)
|
1.1 score on a scale
STANDARD_DEVIATION 1.3 • n=99 Participants
|
1.2 score on a scale
STANDARD_DEVIATION 1.5 • n=102 Participants
|
1.1 score on a scale
STANDARD_DEVIATION 1.4 • n=201 Participants
|
|
Neuropsychiatric Inventory Questionnaire (NPI-Q: Caregiver Distress)
|
10.8 score on a scale
STANDARD_DEVIATION 9.2 • n=99 Participants
|
10.4 score on a scale
STANDARD_DEVIATION 8.4 • n=102 Participants
|
10.6 score on a scale
STANDARD_DEVIATION 8.8 • n=201 Participants
|
|
Patient Health Questionnaire (PHQ-8: Caregiver)
|
3.7 score on a scale
STANDARD_DEVIATION 4.2 • n=99 Participants
|
4.1 score on a scale
STANDARD_DEVIATION 4 • n=102 Participants
|
3.9 score on a scale
STANDARD_DEVIATION 4.1 • n=201 Participants
|
|
Caregiver Strain Index
|
6.6 units on a scale
STANDARD_DEVIATION 3.8 • n=99 Participants
|
6.8 units on a scale
STANDARD_DEVIATION 3.5 • n=102 Participants
|
6.7 units on a scale
STANDARD_DEVIATION 3.7 • n=201 Participants
|
PRIMARY outcome
Timeframe: 0-24 monthsPopulation: This outcome measure was collected at baseline, 3, 6, 9 12, 15, 18, 21 and 24 months for each participant active on study at that time point and with a caregiver available to respond. The number entered represents the mean across all time points for both groups.
The Neuropsychiatric Inventory Questionnaire measures the presence and severity of 12 neuropsychiatric symptoms in the person with dementia (PWD) in the past month per caregiver report. Each symptom reported as present is scored on a scale of 1-3 with higher scores indicating more severity of the symptom: mild, moderate, or severe. The NPI-Q Patient Symptom and Severity total score is constructed by summing the value of each presenting symptom's severity and ranges from 0-36 with higher scores indicating more severe patient neuropsychiatric symptoms.
Outcome measures
| Measure |
IN-PEACE Dementia Care Coordination
n=99 Participants
IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.
IN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.
|
Usual Care
n=102 Participants
The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study.
|
|---|---|---|
|
Neuropsychiatric Inventory Questionnaire (NPI-Q) for Patient Symptom and Severity
|
9.149 score on a scale
Standard Deviation 0.747
|
9.39 score on a scale
Standard Deviation 0.756
|
SECONDARY outcome
Timeframe: 0-24 monthsPopulation: This outcome measure was collected at baseline, 3, 6, 9 12, 15, 18, 21 and 24 months for each participant active on study at that time point and with a caregiver available to respond. The number entered represents the mean across all time points for both groups.
The Symptom Measures in End-of-Life Dementia (SM-EOLD) measures the presence and frequency of 9 symptoms experienced by the person with dementia (PWD) in the previous 90 days per caregiver report: pain, shortness of breath, depression, fear, anxiety, agitation, calm, skin breakdown, and resistance to care. Each symptom is scored on a scale ranging 0 - 5 (daily, several days a week, once a week, 2 or 3 days a month, once a month, never) with higher scores indicating better symptom control. The SM-EOLD total score is constructed by summing the value of each item, and ranges from 0-45 with higher scores indicating better symptom control (comfort).
Outcome measures
| Measure |
IN-PEACE Dementia Care Coordination
n=99 Participants
IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.
IN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.
|
Usual Care
n=102 Participants
The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study.
|
|---|---|---|
|
Symptom Management - End of Life for Dementia (SM-EOLD)
|
28.36 score on a scale
Standard Deviation 0.972
|
26.133 score on a scale
Standard Deviation 0.984
|
SECONDARY outcome
Timeframe: 0-24 monthsPopulation: This outcome measure was collected at baseline, 3, 6, 9 12, 15, 18, 21 and 24 months for each participant active on study at that time point and with a caregiver available to respond. The number entered represents the mean across all time points for both groups.
The Patient Health Questionnaire-8 item measures the frequency of depressive symptoms experienced by the caregiver in the last two weeks per caregiver report. Each symptom is scored on a scale of 0-3 (not at all, several days, more than half the days, nearly every day) with higher scores indicating more frequency of depressive symptoms. The PHQ-8 Caregiver total score is constructed by summing the value of each item and ranges from 0-24 with higher scores indicating more frequent depressive symptoms in the caregiver.
Outcome measures
| Measure |
IN-PEACE Dementia Care Coordination
n=99 Participants
IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.
IN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.
|
Usual Care
n=102 Participants
The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-8) Caregiver
|
4.472 score on a scale
Standard Deviation 0.507
|
4.522 score on a scale
Standard Deviation 0.511
|
SECONDARY outcome
Timeframe: 0-24 monthsPopulation: This outcome measure was collected at baseline, 3, 6, 9 12, 15, 18, 21 and 24 months for each participant active on study at that time point and with a caregiver available to respond. The number entered represents the mean across all time points for both groups.
The Neuropsychiatric Inventory Questionnaire measures the presence and severity of 12 neuropsychiatric symptoms in the person with dementia (PWD) in the past month per caregiver report. If the symptom was reported as present, then the caregiver rated the level of distress they experienced related to the patient's symptom on a scale of 0-5 with higher scores indicating more distress. The NPI-Q Caregiver Distress total score is constructed by summing the value of each distress item and ranges from 0-60 with higher scores indicating more caregiver distress.
Outcome measures
| Measure |
IN-PEACE Dementia Care Coordination
n=99 Participants
IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.
IN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.
|
Usual Care
n=102 Participants
The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study.
|
|---|---|---|
|
Neuropsychiatric Inventory Questionnaire (NPI-Q) Caregiver Distress
|
9.282 score on a scale
Standard Deviation 1.063
|
10.148 score on a scale
Standard Deviation 1.073
|
SECONDARY outcome
Timeframe: 0-24 monthsPopulation: As pre-specified, this data only includes the patient from each dyad and not the caregiver.
Combined measure of counts of emergency department (ED) visits and hospital admissions drawn from hospital reported data in the Indiana Network for Patient Care (INPC) database, managed by the Indiana Health Information Exchange (IHIE). As pre-specified, this data only includes the patient from each dyad and not the caregiver.
Outcome measures
| Measure |
IN-PEACE Dementia Care Coordination
n=99 Participants
IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.
IN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.
|
Usual Care
n=102 Participants
The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study.
|
|---|---|---|
|
Emergency Department Visits and Hospitalizations
|
50 Participants
|
80 Participants
|
Adverse Events
IN-PEACE Dementia Care Coordination
Serious events: 50 serious events
Other events: 77 other events
Deaths: 40 deaths
Usual Care
Serious events: 61 serious events
Other events: 89 other events
Deaths: 43 deaths
Serious adverse events
| Measure |
IN-PEACE Dementia Care Coordination
n=99 participants at risk
IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.
IN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.
|
Usual Care
n=102 participants at risk
The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study.
|
|---|---|---|
|
General disorders
Hospitalizations
|
50.5%
50/99 • Number of events 82 • Through study completion, up to 24 months or the death of the patient
Adverse events could be reported by caregivers during intervention visits and also were systematically collected for both arms every three months: death, emergency department visits, hospitalizations, falls, elopements, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events. Death is an expected outcome for the patient population's condition under study.
|
59.8%
61/102 • Number of events 113 • Through study completion, up to 24 months or the death of the patient
Adverse events could be reported by caregivers during intervention visits and also were systematically collected for both arms every three months: death, emergency department visits, hospitalizations, falls, elopements, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events. Death is an expected outcome for the patient population's condition under study.
|
Other adverse events
| Measure |
IN-PEACE Dementia Care Coordination
n=99 participants at risk
IN-PEACE intervention arm will have monthly contact with a dementia care coordinator (DCC) to to identify symptoms the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors.
IN-PEACE Dementia Care Coordination: Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.
|
Usual Care
n=102 participants at risk
The usual care arm will have access to education and informational materials from the local chapter of the Alzheimer's Association and other community resources and will be reminded of these resources throughout the study.
|
|---|---|---|
|
Nervous system disorders
Falls
|
35.4%
35/99 • Number of events 70 • Through study completion, up to 24 months or the death of the patient
Adverse events could be reported by caregivers during intervention visits and also were systematically collected for both arms every three months: death, emergency department visits, hospitalizations, falls, elopements, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events. Death is an expected outcome for the patient population's condition under study.
|
41.2%
42/102 • Number of events 78 • Through study completion, up to 24 months or the death of the patient
Adverse events could be reported by caregivers during intervention visits and also were systematically collected for both arms every three months: death, emergency department visits, hospitalizations, falls, elopements, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events. Death is an expected outcome for the patient population's condition under study.
|
|
Nervous system disorders
Elopements
|
26.3%
26/99 • Number of events 35 • Through study completion, up to 24 months or the death of the patient
Adverse events could be reported by caregivers during intervention visits and also were systematically collected for both arms every three months: death, emergency department visits, hospitalizations, falls, elopements, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events. Death is an expected outcome for the patient population's condition under study.
|
14.7%
15/102 • Number of events 19 • Through study completion, up to 24 months or the death of the patient
Adverse events could be reported by caregivers during intervention visits and also were systematically collected for both arms every three months: death, emergency department visits, hospitalizations, falls, elopements, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events. Death is an expected outcome for the patient population's condition under study.
|
|
General disorders
Other Accidents
|
8.1%
8/99 • Number of events 12 • Through study completion, up to 24 months or the death of the patient
Adverse events could be reported by caregivers during intervention visits and also were systematically collected for both arms every three months: death, emergency department visits, hospitalizations, falls, elopements, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events. Death is an expected outcome for the patient population's condition under study.
|
6.9%
7/102 • Number of events 12 • Through study completion, up to 24 months or the death of the patient
Adverse events could be reported by caregivers during intervention visits and also were systematically collected for both arms every three months: death, emergency department visits, hospitalizations, falls, elopements, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events. Death is an expected outcome for the patient population's condition under study.
|
|
General disorders
ED Visits
|
60.6%
60/99 • Number of events 125 • Through study completion, up to 24 months or the death of the patient
Adverse events could be reported by caregivers during intervention visits and also were systematically collected for both arms every three months: death, emergency department visits, hospitalizations, falls, elopements, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events. Death is an expected outcome for the patient population's condition under study.
|
79.4%
81/102 • Number of events 212 • Through study completion, up to 24 months or the death of the patient
Adverse events could be reported by caregivers during intervention visits and also were systematically collected for both arms every three months: death, emergency department visits, hospitalizations, falls, elopements, and other accidents. This data was collected only on the patients from each dyad as pre-specified; caregivers were not monitored nor assessed for mortality or adverse events. Death is an expected outcome for the patient population's condition under study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place