Trial Outcomes & Findings for Delivery Models of Caregiver Support and Education (NCT NCT02368132)
NCT ID: NCT02368132
Last Updated: 2023-07-27
Results Overview
The Revised Memory and Behavior Problems Checklist (Reaction Subscale) measures CG distress in response to dementia-related symptoms. The RMBPC CG reaction subscale captured how bothered or upset CGs were in response to each endorsed dementia-related symptom (range=0-96, higher scores denote greater distress in response to symptoms)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
319 participants
Primary outcome timeframe
3 Months
Results posted on
2023-07-27
Participant Flow
Caregivers (CGs) of Veterans with dementia receiving primary care at the Corporal Michael J. Crescenz VA Medical Center, VA Western New York Healthcare System, and their affiliated outpatient clinics were recruited and enrolled between May 2016 and November 2019. Participants were sent a letter introducing them to the study following either direct provider referral or upon a review of lists of patients prescribed memory-enhancing medications generated from the electronic medical record.
Participant milestones
| Measure |
Usual Care
Caregivers randomized to UC will be sent general material about VA and community resources for patients with dementia and their CGs. With the exception of this material, individuals in this group will receive usual care and will be contacted again at 3, 6, and 12 months for follow-up research assessments.
|
Individual Delivered TEP Arm
Two mandatory modules that cover the stages of dementia and provide a brief introduction to problem solving techniques, action plan development, and coping skills, plus a menu of additional modules covering various content areas evaluated during the course of the monthly assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, longterm planning, etc.). Each individual TEP session will begin with reviewing education related to the selected module. The remainder of each session will involve coaching the caregiver on emotion-focused and problem focused coping strategies. The care manager will also discuss problem solving with the CG to reinforce the action plan and the educational component of the intervention.
|
Group Delivered TEP Arm
All TEP modules will be in a group format. Each call will take 1.5-2 hours. Each group will be comprised of 5-8 CGs who will call into a teleconference line at a pre-specified time. Groups will include spouse/partner-only or adult child-only CGs. The content of the calls will mirror those in the individual TEP delivered program. In addition to the group calls, they will receive individual care management.
|
|---|---|---|---|
|
Overall Study
STARTED
|
112
|
122
|
85
|
|
Overall Study
COMPLETED
|
32
|
71
|
50
|
|
Overall Study
NOT COMPLETED
|
80
|
51
|
35
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Delivery Models of Caregiver Support and Education
Baseline characteristics by cohort
| Measure |
Usual Care
n=112 Participants
Caregivers randomized to UC will be sent general material about VA and community resources for patients with dementia and their CGs. With the exception of this material, individuals in this group will receive usual care and will be contacted again at 3, 6, and 12 months for follow-up research assessments.
|
Individual Delivered TEP Arm
n=122 Participants
Two mandatory modules that cover the stages of dementia and provide a brief introduction to problem solving techniques, action plan development, and coping skills, plus a menu of additional modules covering various content areas evaluated during the course of the monthly assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, longterm planning, etc.). Each individual TEP session will begin with reviewing education related to the selected module. The remainder of each session will involve coaching the caregiver on emotion-focused and problem focused coping strategies. The care manager will also discuss problem solving with the CG to reinforce the action plan and the educational component of the intervention.
|
Group Delivered TEP Arm
n=85 Participants
All TEP modules will be in a group format. Each call will take 1.5-2 hours. Each group will be comprised of 5-8 CGs who will call into a teleconference line at a pre-specified time. Groups will include spouse/partner-only or adult child-only CGs. The content of the calls will mirror those in the individual TEP delivered program. In addition to the group calls, they will receive individual care management.
|
Total
n=319 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.31 years
STANDARD_DEVIATION 11.36 • n=5 Participants
|
72.20 years
STANDARD_DEVIATION 11.45 • n=7 Participants
|
71.42 years
STANDARD_DEVIATION 11.12 • n=5 Participants
|
71.68 years
STANDARD_DEVIATION 11.30 • n=4 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
298 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
239 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
112 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
319 Participants
n=4 Participants
|
|
Revised Memory and Behavior Problem Checklist (CG Reaction Score)
|
16.23 score on a measure
STANDARD_DEVIATION 11.29 • n=5 Participants
|
20.48 score on a measure
STANDARD_DEVIATION 14.17 • n=7 Participants
|
17.88 score on a measure
STANDARD_DEVIATION 12.38 • n=5 Participants
|
18.29 score on a measure
STANDARD_DEVIATION 12.83 • n=4 Participants
|
|
VR 12 - Mental Component Score
|
48.45 score on a measure
STANDARD_DEVIATION 9.02 • n=5 Participants
|
43.07 score on a measure
STANDARD_DEVIATION 11.38 • n=7 Participants
|
45.88 score on a measure
STANDARD_DEVIATION 11.08 • n=5 Participants
|
44.24 score on a measure
STANDARD_DEVIATION 11.32 • n=4 Participants
|
|
Zarit Burden Interview
|
15.98 score on a measure
STANDARD_DEVIATION 7.40 • n=5 Participants
|
20.29 score on a measure
STANDARD_DEVIATION 9.04 • n=7 Participants
|
19.63 score on a measure
STANDARD_DEVIATION 9.09 • n=5 Participants
|
18.63 score on a measure
STANDARD_DEVIATION 8.72 • n=4 Participants
|
PRIMARY outcome
Timeframe: 3 MonthsPopulation: Intent-to-treat analysis included all randomized participants
The Revised Memory and Behavior Problems Checklist (Reaction Subscale) measures CG distress in response to dementia-related symptoms. The RMBPC CG reaction subscale captured how bothered or upset CGs were in response to each endorsed dementia-related symptom (range=0-96, higher scores denote greater distress in response to symptoms)
Outcome measures
| Measure |
Usual Care
n=112 Participants
Caregivers randomized to UC will be sent general material about VA and community resources for patients with dementia and their CGs. With the exception of this material, individuals in this group will receive usual care and will be contacted again at 3, 6, and 12 months for follow-up research assessments.
|
Individual Delivered TEP Arm
n=122 Participants
Two mandatory modules that cover the stages of dementia and provide a brief introduction to problem solving techniques, action plan development, and coping skills, plus a menu of additional modules covering various content areas evaluated during the course of the monthly assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, longterm planning, etc.). Each individual TEP session will begin with reviewing education related to the selected module. The remainder of each session will involve coaching the caregiver on emotion-focused and problem focused coping strategies. The care manager will also discuss problem solving with the CG to reinforce the action plan and the educational component of the intervention.
|
Group Delivered TEP Arm
n=85 Participants
All TEP modules will be in a group format. Each call will take 1.5-2 hours. Each group will be comprised of 5-8 CGs who will call into a teleconference line at a pre-specified time. Groups will include spouse/partner-only or adult child-only CGs. The content of the calls will mirror those in the individual TEP delivered program. In addition to the group calls, they will receive individual care management.
|
|---|---|---|---|
|
Revised Memory and Behavior Problems Checklist (Reaction Subscale)
|
19.46 score on a scale
Standard Error 1.97
|
14.31 score on a scale
Standard Error 1.41
|
10.73 score on a scale
Standard Error 1.65
|
PRIMARY outcome
Timeframe: 3 MonthsPopulation: Intent-to-treat analysis included all randomized participants
The 12-item Zarit Burden Interview was administered to assess CGs' perceived caregiving burden (range=0-48, higher scores denote greater burden)
Outcome measures
| Measure |
Usual Care
n=112 Participants
Caregivers randomized to UC will be sent general material about VA and community resources for patients with dementia and their CGs. With the exception of this material, individuals in this group will receive usual care and will be contacted again at 3, 6, and 12 months for follow-up research assessments.
|
Individual Delivered TEP Arm
n=122 Participants
Two mandatory modules that cover the stages of dementia and provide a brief introduction to problem solving techniques, action plan development, and coping skills, plus a menu of additional modules covering various content areas evaluated during the course of the monthly assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, longterm planning, etc.). Each individual TEP session will begin with reviewing education related to the selected module. The remainder of each session will involve coaching the caregiver on emotion-focused and problem focused coping strategies. The care manager will also discuss problem solving with the CG to reinforce the action plan and the educational component of the intervention.
|
Group Delivered TEP Arm
n=85 Participants
All TEP modules will be in a group format. Each call will take 1.5-2 hours. Each group will be comprised of 5-8 CGs who will call into a teleconference line at a pre-specified time. Groups will include spouse/partner-only or adult child-only CGs. The content of the calls will mirror those in the individual TEP delivered program. In addition to the group calls, they will receive individual care management.
|
|---|---|---|---|
|
Zarit Burden Interview (12 Item)
|
16.66 score on a scale
Standard Error 1.25
|
17.95 score on a scale
Standard Error 0.93
|
17.37 score on a scale
Standard Error 1.09
|
PRIMARY outcome
Timeframe: 3 MonthsPopulation: Intent-to-treat analysis included all randomized participants
Perceived overall mental wellbeing were assessed with the Mental Component Score (MCS) subscale of the Veterans RAND 12-Item Health Survey (VR12). Higher scores denote greater mental wellbeing (range: 0-100)
Outcome measures
| Measure |
Usual Care
n=112 Participants
Caregivers randomized to UC will be sent general material about VA and community resources for patients with dementia and their CGs. With the exception of this material, individuals in this group will receive usual care and will be contacted again at 3, 6, and 12 months for follow-up research assessments.
|
Individual Delivered TEP Arm
n=122 Participants
Two mandatory modules that cover the stages of dementia and provide a brief introduction to problem solving techniques, action plan development, and coping skills, plus a menu of additional modules covering various content areas evaluated during the course of the monthly assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, longterm planning, etc.). Each individual TEP session will begin with reviewing education related to the selected module. The remainder of each session will involve coaching the caregiver on emotion-focused and problem focused coping strategies. The care manager will also discuss problem solving with the CG to reinforce the action plan and the educational component of the intervention.
|
Group Delivered TEP Arm
n=85 Participants
All TEP modules will be in a group format. Each call will take 1.5-2 hours. Each group will be comprised of 5-8 CGs who will call into a teleconference line at a pre-specified time. Groups will include spouse/partner-only or adult child-only CGs. The content of the calls will mirror those in the individual TEP delivered program. In addition to the group calls, they will receive individual care management.
|
|---|---|---|---|
|
Veterans RAND 12-Item Health Survey (VR12)
|
49.28 score on a scale
Standard Error 1.52
|
45.29 score on a scale
Standard Error 1.11
|
46.20 score on a scale
Standard Error 1.32
|
Adverse Events
Usual Care
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Individual Delivered TEP Arm
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Group Delivered TEP Arm
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Care
n=112 participants at risk
Caregivers randomized to UC will be sent general material about VA and community resources for patients with dementia and their CGs. With the exception of this material, individuals in this group will receive usual care and will be contacted again at 3, 6, and 12 months for follow-up research assessments.
|
Individual Delivered TEP Arm
n=122 participants at risk
Two mandatory modules that cover the stages of dementia and provide a brief introduction to problem solving techniques, action plan development, and coping skills, plus a menu of additional modules covering various content areas evaluated during the course of the monthly assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, longterm planning, etc.). Each individual TEP session will begin with reviewing education related to the selected module. The remainder of each session will involve coaching the caregiver on emotion-focused and problem focused coping strategies. The care manager will also discuss problem solving with the CG to reinforce the action plan and the educational component of the intervention.
|
Group Delivered TEP Arm
n=85 participants at risk
All TEP modules will be in a group format. Each call will take 1.5-2 hours. Each group will be comprised of 5-8 CGs who will call into a teleconference line at a pre-specified time. Groups will include spouse/partner-only or adult child-only CGs. The content of the calls will mirror those in the individual TEP delivered program. In addition to the group calls, they will receive individual care management.
|
|---|---|---|---|
|
General disorders
Hospitalization/ER
|
0.00%
0/112 • Up to 1 year following baseline assessment
|
2.5%
3/122 • Number of events 3 • Up to 1 year following baseline assessment
|
0.00%
0/85 • Up to 1 year following baseline assessment
|
|
General disorders
Hospitalization due to surgery
|
0.89%
1/112 • Number of events 1 • Up to 1 year following baseline assessment
|
1.6%
2/122 • Number of events 2 • Up to 1 year following baseline assessment
|
3.5%
3/85 • Number of events 3 • Up to 1 year following baseline assessment
|
|
General disorders
Hospitalization - Illness
|
1.8%
2/112 • Number of events 2 • Up to 1 year following baseline assessment
|
0.82%
1/122 • Number of events 1 • Up to 1 year following baseline assessment
|
1.2%
1/85 • Number of events 1 • Up to 1 year following baseline assessment
|
|
General disorders
Surgery
|
0.00%
0/112 • Up to 1 year following baseline assessment
|
0.82%
1/122 • Number of events 1 • Up to 1 year following baseline assessment
|
2.4%
2/85 • Number of events 2 • Up to 1 year following baseline assessment
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Shahrzad Mavandadi
Corporal Michael J Crescenz VA Medical Center
Phone: 215.823.5211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place