The REACH Intervention for Caregivers of Veterans and Service Members With TBI
- Conditions
- CaregiverTraumatic Brain Injury
- Interventions
- Other: REACH TBI
- Registration Number
- NCT06111794
- Lead Sponsor
- University of Virginia
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Waitlist Control REACH TBI Participants will receive the REACH TBI psychoeducational intervention. REACH TBI REACH TBI Participants will receive the REACH TBI psychoeducational intervention.
- Primary Outcome Measures
Name Time Method TBI-CareQOL Caregiver Strain - Short Form 6a Baseline; 3 months (post-intervention); 6 month follow-up It assesses caregiver strain in caregivers of individuals with TBI. Values range from 6-30, with higher scores indicating greater strain/worse outcome.
- Secondary Outcome Measures
Name Time Method Patient-Reported Outcomes Measurement Information System Emotional Distress - Depression - Short Form 4a Baseline; 3 months (post-intervention); 6 month follow-up It assesses caregiver depression. Values range from 8-40, with higher scores indicating greater depression/worse outcome.
Patient-Reported Outcomes Measurement Information System Emotional Distress - Anxiety - Short Form 4a Baseline; 3 months (post-intervention); 6 month follow-up It assesses caregiver anxiety. Values range from 7-35, with higher scores indicating greater anxiety/worse outcome.
TBI-CareQOL Health Care Frustration - Self - Short Form 6a Baseline; 3 months (post-intervention); 6 month follow-up 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.
Patient-Reported Outcomes Measurement Information System - General Self-Efficacy Baseline; 3 months (post-intervention); 6 month follow-up It assesses caregiver self-efficacy. Values from range 10-50, with higher scores indicating greater self-efficacy/better outcome.
Trial Locations
- Locations (1)
Tampa VA Medical Center
🇺🇸Tampa, Florida, United States