Caregiver, Traumatic Brain Injury
Conditions
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.
Interventions
OTHERREACH TBI
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.
Sponsors
James A. Haley Veterans Administration Hospital
Virginia Commonwealth University
University of Utah
University of Tennessee
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This study uses a treatment/waitlist-control crossover repeated-measures design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Contacts
Primary ContactPaul B Perrin, PhD
Outcome results
None listed