Dementia, Mixed, Dementia of Alzheimer Type, TBI (Traumatic Brain Injury)
Conditions
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.
Interventions
OTHERREACH Hope
REACH VA (Resources for Enhancing All Caregivers Health in Department of Veterans Affairs) and the DoD's Virtual Hope Box. For REACH Hope, as the caregiver and interventionist work on strategies one-on-one, these will be integrated into the Hope Box for the caregiver to use between and after sessions.
Sponsors
Virginia Commonwealth University
University of Tennessee
Memphis VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
The study is a wait list control design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Burden at three months | three months | Measured by the Zarit Burden Inventory- 12 |
| Change from baseline Burden at six months | six months | Measured by the Zarit Burden Inventory- 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline Anxiety at three months | Three months | As measured with the General Anxiety Disorders-7 |
| Change from baseline Anxiety at six months | six months | As measured with the General Anxiety Disorders-7 |
| Change from baseline Depression at three months | Three months | As measured with the Patient Health Questionnaire-9 |
| Change from baseline Caregiving self-efficacy at six months | six months | As measured with the Caregiving Self-Efficacy scale |
| Change from baseline Caregiving self-efficacy at three months | three months | As measured with the Caregiving Self-Efficacy scale |
| Change from baseline Depression at six months | Six months | As measured with the Patient Health Questionnaire-9 |
Countries
United States
Outcome results
None listed