Delivery Models of Caregiver Support and Education
Comparative Effectiveness of Delivery Methods for Caregiver Support and Education
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Existing interventions for informal caregivers (CGs) of care recipients (CRs) with dementia vary on multiple dimensions (e.g., content, administration time, mode of delivery), and findings indicate that these programs are effective in improving CG and CR outcomes. The investigators' team has developed and evaluated two CG programs that are unique in that they are relatively brief (i.e., 3 months) and rely solely on telephone administration. The original program, the Telehealth Education Program (TEP), provides CG support, psychoeducation, and skills training in a group format. The second program adapted the original TEP to be delivered to individual CGs and includes collaborative care management services. Key components of this CR/CG-centered program include direct collaboration among teams of care managers, primary care providers (PCPs), and CGs. The decision to develop an individually-tailored, collaborative care program was partly in response to the success of collaborative care models with other patient populations and the fact that the majority of individuals with dementia receive their healthcare from their PCPs. Nonetheless, an individually-delivered program lacks the benefits derived from the mutual peer support and feedback provided by group-based interventions. What remains to be determined, therefore, is whether modifying the individually-delivered care management program to deliver TEP in a group format is more effective than the individually-delivered program alone.
Objectives: The objectives of the project include: a) testing the comparative effectiveness of 2 delivery models (individual TEP + individual care management vs. group TEP + individual care management) of a telephone-based, collaborative dementia care intervention for CGs, and b) exploring whether the individual or individual + group intervention is more effective/acceptable among spousal vs. adult children CGs.
Methods: To meet these objectives, the investigators will use a prospective, randomized control group, repeated measures (i.e., baseline, 3, 6, and 12 month follow-up) design. Participants will include 405 CGs (spouses and children 18 years of age and older) of Veterans diagnosed with dementia and receiving routine clinical care at two VA sites. CGs will be recruited for participation if they live with and/or provide 4+ hours of care/day. CGs will be randomly assigned to usual care, the individual intervention, or the individual + group intervention. The main objectives of both interventions are to facilitate resource connection and provide education, psychosocial support, and care management for individuals caring for Veterans with dementia, thereby improving access to and use of non-institutional services, rates of guideline adherent care, and CG/CR outcomes. In both interventions, CGs will receive education, continuous support, skills training, and monitoring of Veterans' medication adherence, symptoms, and service needs. CGs will be asked to complete an assessment battery of standardized measures of CR- and CG-characteristics. Veterans' clinical medical records (including cost data) also will be evaluated for screening and clinical data collection purposes. Generalized estimating equations (GEE) will be the primary method used to analyze the nested, longitudinal data.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14215-1129
- VA Western New York Healthcare System, Buffalo, NY
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104-4551
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 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.
|
|
|
Active Comparator: 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.
|
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.
|
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Revised Memory and Behavior Problems Checklist (Reaction Subscale)
Time Frame: 3 Months
|
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)
Time Frame: 3 Months
|
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)
Time Frame: 3 Months
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Shahrzad Mavandadi, PhD, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 14-080
- 01548 (Other Identifier: IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.