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| Name | Class |
|---|---|
| James A. Haley Veterans Administration Hospital | FED |
| Virginia Commonwealth University | OTHER |
| University of Utah | OTHER |
| University of Tennessee |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REACH TBI | Experimental | Participants will receive the REACH TBI psychoeducational intervention. |
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| Waitlist Control | Active Comparator | Participants will receive the REACH TBI psychoeducational intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REACH TBI | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
To be eligible for the study, the participant must:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul B Perrin, PhD | Contact | (434) 982-2600 | perrin@virginia.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa VA Medical Center | Recruiting | Tampa | Florida | 33612 | United States |
De-identified individual participant data are available to other researchers via FITBIR.
Data will become available at the end of data collection and cleaning and will be available for a period of at least 5 years.
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
This study uses a treatment/waitlist-control crossover repeated-measures design.
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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 |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |