N/A
Completed N=319
Delivery Models of Caregiver Support and Education
Source: ClinicalTrials.gov NCT02368132 ↗Enrolled (actual)
319
Serious AEs
5.0%
Results posted
Jun 2022
Primary outcomePrimary: Revised Memory and Behavior Problems Checklist (Reaction Subscale) — 19.46; 14.31; 10.73 score on a scale — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Revised Memory and Behavior Problems Checklist (Reaction Subscale) |
19.46; 14.31; 10.73 | <0.001 sig |
| PRIMARY Zarit Burden Interview (12 Item) |
16.66; 17.95; 17.37 | — |
| PRIMARY Veterans RAND 12-Item Health Survey (VR12) |
49.28; 45.29; 46.20 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02368132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.