Trial Outcomes & Findings for Partners in Dementia Care: A Telephone Care Consultation Intervention Provided to Veterans in Partnership With Local Alzheimer's Association Chapters (NCT NCT00291161)
NCT ID: NCT00291161
Last Updated: 2016-05-19
Results Overview
The following outcomes were measured in Caregivers via scales administered to each caregiver: Unmet need (range=0 to 39, higher meaning more unmet needs); Role captivity (range=0-9, higher indicating greater role captivity); Physical health strain (range=0-9, higher indicating greater health strain); Relationship strain (range=0-18, higher indicating greater relationship strain); Depression (range=0-22, higher indicating greater depression); Caregiver support service use (the number of support services utilized, 0-2); Number of informal helpers (range=0-50, higher indicating more informal helpers)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
994 participants
Primary outcome timeframe
Baseline and at six months
Results posted on
2016-05-19
Participant Flow
Participant milestones
| Measure |
Veterans: Partners in Dementia Care Intervention
A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
|
Veterans: Usual Care Comparison
Patients and caregivers were provided usual care and an educational booklet on dementia
|
Caregivers: Partners in Dementia Care Intervention
Caregivers for Veterans assigned to the Partners in Dementia Care Intervention
|
Caregivers: Usual Care Comparison
Caregivers of the Veterans assigned to the Usual Care Comparison
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
316
|
192
|
299
|
187
|
|
Overall Study
COMPLETED
|
235
|
134
|
206
|
122
|
|
Overall Study
NOT COMPLETED
|
81
|
58
|
93
|
65
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Partners in Dementia Care: A Telephone Care Consultation Intervention Provided to Veterans in Partnership With Local Alzheimer's Association Chapters
Baseline characteristics by cohort
| Measure |
Veterans-PDC Group
n=316 Participants
Veterans with diagnosed dementia receiving the PDC Intervention
|
Veterans-Usual Care Comparison Group
n=192 Participants
Veterans with diagnosed dementia receiving educational materials and usual care
|
Caregivers-PDC Group
n=299 Participants
Caregivers to veterans with diagnosed dementia receiving the PDC Intervention
|
Caregivers-Usual Care Comparison Group
n=187 Participants
Caregivers to veterans with diagnosed dementia receiving educational materials and usual care
|
Total
n=994 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Age of Veterans
|
79.4 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
80.7 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=4 Participants
|
79.9 years
STANDARD_DEVIATION 7.6 • n=21 Participants
|
|
Age, Continuous
Age of Caregivers
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
68.0 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
70.8 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
69.1 years
STANDARD_DEVIATION 12.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
283 Participants
n=5 Participants
|
178 Participants
n=4 Participants
|
475 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
305 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
519 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White nonhispanic
|
234 participants
n=5 Participants
|
178 participants
n=7 Participants
|
222 participants
n=5 Participants
|
170 participants
n=4 Participants
|
804 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black nonhispanic
|
64 participants
n=5 Participants
|
11 participants
n=7 Participants
|
56 participants
n=5 Participants
|
14 participants
n=4 Participants
|
145 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
12 participants
n=5 Participants
|
0 participants
n=7 Participants
|
16 participants
n=5 Participants
|
0 participants
n=4 Participants
|
28 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
3 participants
n=4 Participants
|
17 participants
n=21 Participants
|
|
Number of Caregivers Who were Spouses
Caregivers who were spouses
|
NA participants
n=5 Participants
|
NA participants
n=7 Participants
|
204 participants
n=5 Participants
|
149 participants
n=4 Participants
|
NA participants
n=21 Participants
|
|
Number of Caregivers Who were Spouses
Caregivers who were not spouses
|
NA participants
n=5 Participants
|
NA participants
n=7 Participants
|
95 participants
n=5 Participants
|
38 participants
n=4 Participants
|
NA participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and at six monthsPopulation: Data were collected for caregivers only
The following outcomes were measured in Caregivers via scales administered to each caregiver: Unmet need (range=0 to 39, higher meaning more unmet needs); Role captivity (range=0-9, higher indicating greater role captivity); Physical health strain (range=0-9, higher indicating greater health strain); Relationship strain (range=0-18, higher indicating greater relationship strain); Depression (range=0-22, higher indicating greater depression); Caregiver support service use (the number of support services utilized, 0-2); Number of informal helpers (range=0-50, higher indicating more informal helpers)
Outcome measures
| Measure |
Caregivers: Partners in Dementia Care Intervention
n=299 Participants
A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
|
Caregivers: Usual Care Comparison
n=187 Participants
Patients and caregivers were provided usual care and an educational booklet on dementia
|
|---|---|---|
|
Caregiver Outcomes
Physical Health Strain at Baseline
|
3.7 units on a scale
Standard Deviation 1.6
|
3.6 units on a scale
Standard Deviation 1.3
|
|
Caregiver Outcomes
Relationship Strain at Baseline
|
7.2 units on a scale
Standard Deviation 2.5
|
6.8 units on a scale
Standard Deviation 2.1
|
|
Caregiver Outcomes
Number of informal helpers at baseline
|
4.3 units on a scale
Standard Deviation 4.8
|
4.3 units on a scale
Standard Deviation 5.1
|
|
Caregiver Outcomes
Unmet need at Baseline
|
18.6 units on a scale
Standard Deviation 11.8
|
14.5 units on a scale
Standard Deviation 11.2
|
|
Caregiver Outcomes
Unmet need at Six months
|
10.0 units on a scale
Standard Deviation 9.9
|
10.5 units on a scale
Standard Deviation 10.0
|
|
Caregiver Outcomes
Role Captivity at baseline
|
3.7 units on a scale
Standard Deviation 1.6
|
3.5 units on a scale
Standard Deviation 1.4
|
|
Caregiver Outcomes
Role Captivity at 6 months
|
3.6 units on a scale
Standard Deviation 1.6
|
3.2 units on a scale
Standard Deviation 1.6
|
|
Caregiver Outcomes
Physical Health Strain at 6 months
|
3.5 units on a scale
Standard Deviation 1.4
|
3.6 units on a scale
Standard Deviation 1.5
|
|
Caregiver Outcomes
Relationship Strain at 6 months
|
7.0 units on a scale
Standard Deviation 2.6
|
6.3 units on a scale
Standard Deviation 2.3
|
|
Caregiver Outcomes
Caregiver Support Service use at baseline
|
.4 units on a scale
Standard Deviation .7
|
.4 units on a scale
Standard Deviation .7
|
|
Caregiver Outcomes
Caregiver support service at 6 months
|
.7 units on a scale
Standard Deviation .7
|
.5 units on a scale
Standard Deviation .7
|
|
Caregiver Outcomes
Depression at baseline
|
4.5 units on a scale
Standard Deviation 3.9
|
4.0 units on a scale
Standard Deviation 2.9
|
|
Caregiver Outcomes
Depression at 6 months
|
4.7 units on a scale
Standard Deviation 3.9
|
5.0 units on a scale
Standard Deviation 4.1
|
|
Caregiver Outcomes
Number of informal helpers at 6 month
|
4.7 units on a scale
Standard Deviation 5.8
|
4.8 units on a scale
Standard Deviation 9.1
|
PRIMARY outcome
Timeframe: Baseline - six monthsPopulation: Data were collected for veterans who could be interviewed only.
The following outcomes were measured for veterans via scales administered to each veteran: Unmet need (range=0 to 24, higher meaning more unmet needs); Embarrassment about memory problems (range=0-3, higher indicating greater embarrassment); Isolation (range=0-4, higher indicating greater isolation); Relationship strain (range=0-4, higher indicating greater relationship strain); Depression (range=0-11, higher indicating greater depression).
Outcome measures
| Measure |
Caregivers: Partners in Dementia Care Intervention
n=152 Participants
A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
|
Caregivers: Usual Care Comparison
n=103 Participants
Patients and caregivers were provided usual care and an educational booklet on dementia
|
|---|---|---|
|
Veteran Outcomes
Isolation at baseline
|
1.38 units on a scale
Standard Deviation 1.49
|
1.06 units on a scale
Standard Deviation 1.30
|
|
Veteran Outcomes
Isolation at 6 months
|
1.13 units on a scale
Standard Deviation 1.39
|
1.09 units on a scale
Standard Deviation 1.37
|
|
Veteran Outcomes
Embarrassment about memory problems at baseline
|
1.02 units on a scale
Standard Deviation 1.19
|
.89 units on a scale
Standard Deviation 1.08
|
|
Veteran Outcomes
Embarrassment about memory problems at 6 months
|
.82 units on a scale
Standard Deviation 1.09
|
.91 units on a scale
Standard Deviation 1.10
|
|
Veteran Outcomes
Depression at baseline
|
2.68 units on a scale
Standard Deviation 2.44
|
2.19 units on a scale
Standard Deviation 2.10
|
|
Veteran Outcomes
Depression at 6 months
|
2.52 units on a scale
Standard Deviation 2.59
|
2.37 units on a scale
Standard Deviation 2.34
|
|
Veteran Outcomes
Unmet need at baseline
|
7.00 units on a scale
Standard Deviation 6.93
|
5.44 units on a scale
Standard Deviation 6.00
|
|
Veteran Outcomes
Unmet need at 6 months
|
5.05 units on a scale
Standard Deviation 6.14
|
4.40 units on a scale
Standard Deviation 5.58
|
|
Veteran Outcomes
Relationship strain at baseline
|
.46 units on a scale
Standard Deviation 1.04
|
.38 units on a scale
Standard Deviation .87
|
|
Veteran Outcomes
Relationship strain at 6 months
|
.49 units on a scale
Standard Deviation 1.02
|
.32 units on a scale
Standard Deviation .79
|
Adverse Events
Veterans-PDC Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Veterans-Usual Care Comparison Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place