Supporting Caregivers of Veterans With TBI and Mixed Dementia: The REACH Hope Behavioral Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Memphis VA Medical Center
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Change from baseline Burden at three months
Study Overview
Brief Summary
This three-year randomized clinical trial will evaluate a behavioral intervention for caregivers of Veterans with traumatic brain injury (TBI) and Alzheimer's dementia or mixed Dementia (AD/MD) to reduce caregiver depression, anxiety and burden, and improve veterans' health management. The study will combine and deliver two award-winning behavioral interventions - REACH VA (Resources for Enhancing All Caregivers Health in Department of Veterans Affairs) and the DoD's Virtual Hope Box, which we call REACH Hope. Both REACH and Hope Box have evidence of effectiveness individually but have not been delivered together for caregivers supporting veterans with complex neurodegenerative diagnoses and health conditions. Our primary hypothesis is that REACH Hope will improve caregivers' quality of life as measured by reduced burden.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •primary caregiver for person with diagnosis of TBI and subsequent dementia
- •at least one activity of daily living limitation or 2 or more instrumental activity of daily living limitation
- •provide 4 or more hours of care per day for at least 6 months
- •endorse a score of at least high burden (>8) on the Zarit Burden Inventory-4
Exclusion Criteria
- •no mobile telephone or electronic device that can accept the Hope Box application
- •current diagnosis of schizophrenia or other major mental illness
- •auditory impairment that would make telephone use difficult
Arms & Interventions
REACH Hope
Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app.
Intervention: REACH Hope (Other)
Wait list control
Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app.
Intervention: REACH Hope (Other)
Outcomes
Primary Outcomes
Change from baseline Burden at three months
Time Frame: three months
Measured by the Zarit Burden Inventory- 12
Change from baseline Burden at six months
Time Frame: six months
Measured by the Zarit Burden Inventory- 12
Secondary Outcomes
- Change from baseline Anxiety at three months(Three months)
- Change from baseline Caregiving self-efficacy at three months(three months)
- Change from baseline Depression at three months(Three months)
- Change from baseline Depression at six months(Six months)
- Change from baseline Anxiety at six months(six months)
- Change from baseline Caregiving self-efficacy at six months(six months)