REACH Hope Intervention for Dementia and TBI Caregivers

Study Overview
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Brief Summary
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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.

Official Title
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Supporting Caregivers of Veterans With TBI and Mixed Dementia: The REACH Hope Behavioral Intervention

Conditions
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Dementia, Mixed, Dementia of Alzheimer Type, TBI (Traumatic Brain Injury)

Intervention / Treatment
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* Other: REACH Hope


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a wait list control design.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REACH Hope<br>Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app. | Other: REACH Hope<br>* 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.<br>|
| Active Comparator: Wait list control<br>Participants receive the REACH behavioral intervention coupled with the Department of Defense Hope Box app. | Other: REACH Hope<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Burden at three months | Measured by the Zarit Burden Inventory- 12 | three months | 
| Change from baseline Burden at six months | Measured by the Zarit Burden Inventory- 12 | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Depression at three months | As measured with the Patient Health Questionnaire-9 | Three months | 
| Change from baseline Depression at six months | As measured with the Patient Health Questionnaire-9 | Six months | 
| Change from baseline Anxiety at three months | As measured with the General Anxiety Disorders-7 | Three months | 
| Change from baseline Anxiety at six months | As measured with the General Anxiety Disorders-7 | six months | 
| Change from baseline Caregiving self-efficacy at three months | As measured with the Caregiving Self-Efficacy scale | three months | 
| Change from baseline Caregiving self-efficacy at six months | As measured with the Caregiving Self-Efficacy scale | six months |