Clinical trial NCT06111794: The REACH Intervention for Caregivers of Veterans and Service Members With TBI
Official title: The REACH Intervention for Caregivers of Veterans and Service Members With TBI: Efficacy and Implementation Planning Across the VA Polytrauma System of Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Caregiver
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: James A. Haley Veterans Administration Hospital
name: Virginia Commonwealth University
name: University of Utah
name: University of Tennessee
First posted: 2023-11-01
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study uses a treatment/waitlist-control crossover repeated-measures design.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: TBI-CareQOL Caregiver Strain - Short Form 6a
timeFrame: Baseline; 3 months (post-intervention); 6 month follow-up
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System Emotional Distress - Depression - Short Form 4a
timeFrame: Baseline; 3 months (post-intervention); 6 month follow-up
measure: Patient-Reported Outcomes Measurement Information System Emotional Distress - Anxiety - Short Form 4a
timeFrame: Baseline; 3 months (post-intervention); 6 month follow-up
measure: Patient-Reported Outcomes Measurement Information System - General Self-Efficacy
timeFrame: Baseline; 3 months (post-intervention); 6 month follow-up
measure: TBI-CareQOL Health Care Frustration - Self - Short Form 6a
timeFrame: Baseline; 3 months (post-intervention); 6 month follow-up
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa VA Medical Center
state: Florida
Study officials:
References: