Delivery Models of Caregiver Support and Education
Comparative Effectiveness of Delivery Methods for Caregiver Support and Education
2 other identifiers
interventional
319
1 country
2
Brief Summary
The proposed study seeks to compare usual care and two different interventions for caregivers (CGs) of Veterans with dementia that are brief and administered by telephone. In the first intervention, care management (i.e., assistance from a nurse or social worker who works with the CG and Veteran's primary care providers), support, psychoeducation, and skills training are tailored to each individual CG and delivered on an individual basis. In the second intervention, care management is tailored and delivered to each individual CG, but support, psychoeducation, and skills training are delivered (also by phone) in a group format. This study will allow us to examine the added benefit of participating in a CG group that provides mutual peer support and feedback. The investigators also will evaluate the extent to which spousal vs. adult child CGs respond differently to the two interventions. Findings will help refine patient/CG-centered care management and support programs designed to facilitate access to services and improve the quality of life of Veterans with dementia and their families.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2015
CompletedFirst Posted
Study publicly available on registry
February 20, 2015
CompletedStudy Start
First participant enrolled
May 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2021
CompletedResults Posted
Study results publicly available
June 3, 2022
CompletedJuly 27, 2023
July 1, 2023
4.4 years
February 9, 2015
February 28, 2022
July 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Revised Memory and Behavior Problems Checklist (Reaction Subscale)
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)
3 Months
Zarit Burden Interview (12 Item)
The 12-item Zarit Burden Interview was administered to assess CGs' perceived caregiving burden (range=0-48, higher scores denote greater burden)
3 Months
Veterans RAND 12-Item Health Survey (VR12)
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)
3 Months
Study Arms (3)
Usual Care
NO INTERVENTIONCaregivers 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
ACTIVE COMPARATORTwo 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
ACTIVE COMPARATORAll 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Veteran and CG are 18 years of age or older.
- Veteran is community dwelling.
- Veteran has had at least one PACT encounter at the Corporal Michael J. Crescenz VA Medical Center (CMCVAMC), VA Western New York Healthcare System (VAWNYHS), or affiliated community-based outpatient clinics in the past six months at the time that data is extracted from VINCI for recruitment.
- Veteran meets criteria for dementia that is verified by informant report (AD8, score of 2 or above).
- CG endorses that Veteran has a diagnosis of dementia.
- CG lives with or provides care for the Veteran for an average of at least 4 hours per day.
- Veteran's CG is willing and able to provide informed consent.
- CG is either a spouse/partner or adult child.
- CG screens positive for moderate CG burden (per Zarit Burden Interview (4-item) score of 3 or more).
You may not qualify if:
- CG cognitive, hearing, visual, or other physical impairments leading to difficulty with informed consent process, assessment, or participation in intervention visits.
- CG participation in a pre-existing support group or CG intervention at enrollment (however CGs can subsequently enroll in any treatment they choose)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, 14215-1129, United States
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551, United States
Related Publications (1)
Mavandadi S, Ingram E, Chen S, Klaus J, Oslin D. The association between social ties and changes in depressive symptoms among veterans enrolled in a collaborative depression care management program. Psychol Serv. 2022 Feb;19(1):111-117. doi: 10.1037/ser0000496. Epub 2020 Oct 8.
PMID: 33030946RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Significant sample attrition precluded the ability to run comparisons beyond the three month follow-up or more complex interaction models.
Results Point of Contact
- Title
- Dr. Shahrzad Mavandadi
- Organization
- Corporal Michael J Crescenz VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Shahrzad Mavandadi, PhD
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2015
First Posted
February 20, 2015
Study Start
May 13, 2016
Primary Completion
October 13, 2020
Study Completion
February 24, 2021
Last Updated
July 27, 2023
Results First Posted
June 3, 2022
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share