Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT06111794

Conditions

Traumatic Brain Injury

Caregiver

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

REACH TBI

Study Details

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.

Conditions

Traumatic Brain Injury

Caregiver

Study ID

NCT06111794

Start date

Jul 12, 2024

Status verified date

Aug, 2024

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: REACH TBI

Participants will receive the REACH TBI psychoeducational intervention.

active comparator: Waitlist Control

Participants will receive the REACH TBI psychoeducational intervention.

Interventions

REACH 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.

Primary outcome measure

  • TBI-CareQOL Caregiver Strain - Short Form 6a [ Time Frame: Baseline; 3 months (post-intervention); 6 month follow-up ]

Central Contacts and Locations

Central contacts

Paul B Perrin, PhD

(434) 982-2600perrin@virginia.edu

Locations

Tampa VA Medical Center

Recruiting

Tampa, Florida, United States, 33612

More Information

Sponsor

University of Virginia

Last update posted

Aug 9, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2024-08-09.