The REACH Intervention for Caregivers of Veterans and Service Members With TBI

Study Overview
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Brief Summary
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This randomized waitlist control trial will evaluate the effects of a psychoeducational intervention called Resources for Enhancing All Caregivers' Health - Traumatic Brain Injury (REACH TBI) to decrease caregiver strain (primary outcome) and improve caregiver self-efficacy, anxiety, depression, and health care frustrations (secondary outcomes). This study will modify and adapt an award-winning caregiver intervention, Resources for Enhancing All Caregivers Health in the Department of Veterans Affairs (REACH VA), to support the needs of Caregivers of Veterans and Service Members with TBI.

Official Title
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The REACH Intervention for Caregivers of Veterans and Service Members With TBI: Efficacy and Implementation Planning Across the VA Polytrauma System of Care

Conditions
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Traumatic Brain Injury, Caregiver

Intervention / Treatment
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* Other: REACH TBI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible for the study, the participant must: identify as a primary caregiver for a V/SM who sustained a TBI at least 6 months prior; identify as a primary caregiver who has provided care for a V/SM with TBI for at least 6 months; provide some level of daily supervision or assistance with either a physical, cognitive, or behavioral issue they think is likely related to TBI; believe that at least half of their caregiving responsibilities are likely related to TBI rather than another health condition(s); and endorse a score of at least high burden (a score of 8 or higher) on the Zarit Burden Inventory-4. Exclusion Criteria: no telephone; current diagnosis of schizophrenia or other major mental illness; auditory impairment that would make telephone use difficult; or the caregiver believes that more than half of their caregiving for the V/SM is for issues related to another health condition(s) rather than TBI.

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: Crossover Assignment
Interventional Model Description: This study uses a treatment/waitlist-control crossover repeated-measures design.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REACH TBI<br>Participants will receive the REACH TBI psychoeducational intervention. | Other: REACH TBI<br>* Resources for Enhancing All Caregivers' Health - Traumatic Brain Injury (REACH TBI) is a six-session, telephone intervention for Caregivers of Veterans and Services Members with TBI. The intervention focuses on problem solving training, stress management, and psychoeducation. Trained Program Coaches will deliver the REACH TBI intervention by meeting one-on-one via telephone with participants.<br>|
| Active Comparator: Waitlist Control<br>Participants will receive the REACH TBI psychoeducational intervention. | Other: REACH TBI<br>* Resources for Enhancing All Caregivers' Health - Traumatic Brain Injury (REACH TBI) is a six-session, telephone intervention for Caregivers of Veterans and Services Members with TBI. The intervention focuses on problem solving training, stress management, and psychoeducation. Trained Program Coaches will deliver the REACH TBI intervention by meeting one-on-one via telephone with participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TBI-CareQOL Caregiver Strain - Short Form 6a | It assesses caregiver strain in caregivers of individuals with TBI. Values range from 6-30, with higher scores indicating greater strain/worse outcome. | Baseline; 3 months (post-intervention); 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System Emotional Distress - Depression - Short Form 4a | It assesses caregiver depression. Values range from 8-40, with higher scores indicating greater depression/worse outcome. | Baseline; 3 months (post-intervention); 6 month follow-up | 
| Patient-Reported Outcomes Measurement Information System Emotional Distress - Anxiety - Short Form 4a | It assesses caregiver anxiety. Values range from 7-35, with higher scores indicating greater anxiety/worse outcome. | Baseline; 3 months (post-intervention); 6 month follow-up | 
| Patient-Reported Outcomes Measurement Information System - General Self-Efficacy | It assesses caregiver self-efficacy. Values from range 10-50, with higher scores indicating greater self-efficacy/better outcome. | Baseline; 3 months (post-intervention); 6 month follow-up | 
| TBI-CareQOL Health Care Frustration - Self - Short Form 6a | It assesses frustrations a TBI caregiver has had with health care services. Values range from 6-30, with higher scores indicating greater frustration with services received/worse outcome. | Baseline; 3 months (post-intervention); 6 month follow-up |