REACH TBI: The REACH Intervention for Caregivers of Veterans and Service Members With TBI

• Sponsor: University of Virginia (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06111794
• Collaborator: James A. Haley Veterans Administration Hospital (U.S. Fed), Virginia Commonwealth University (Other), University of Utah (Other), University of Tennessee (Other)
• Enrollment: 110
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 29
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury; Caregiver	Other: REACH TBI	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: This study uses a treatment/waitlist-control crossover repeated-measures design.This study uses a treatment/waitlist-control crossover repeated-measures design.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Mar 1, 2024
• Anticipated Primary Completion Date: Aug 1, 2026
• Anticipated Study Completion Date: Aug 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: REACH TBI Participants will receive the REACH TBI psychoeducational intervention.	Other: 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.
Active Comparator: Waitlist Control Participants will receive the REACH TBI psychoeducational intervention.	Other: 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.

Outcome Measures

Primary Outcome Measures

1. Caregiver Strain [Baseline; 3 months (post-intervention); 6 month follow-up]

   Measured by the TBI-CareQOL Caregiver Strain - Short Form 6a

Secondary Outcome Measures

1. Depression [Baseline; 3 months (post-intervention); 6 month follow-up]

   PROMIS Emotional Distress - Depression - Short Form 4a

2. Anxiety [Baseline; 3 months (post-intervention); 6 month follow-up]

   PROMIS Emotional Distress - Anxiety - Short Form 4a

3. Self-Efficacy [Baseline; 3 months (post-intervention); 6 month follow-up]

   PROMIS - General Self-Efficacy

4. Health Care Frustration [Baseline; 3 months (post-intervention); 6 month follow-up]

   TBI-CareQOL Health Care Frustration - Self - Short Form 6a

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampa VA Medical Center	Tampa	Florida	United States	33612

Sponsors and Collaborators

• University of Virginia
• James A. Haley Veterans Administration Hospital
• Virginia Commonwealth University
• University of Utah
• University of Tennessee

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paul B. Perrin, Professor of Data Science and Psychology, University of Virginia
• ClinicalTrials.gov Identifier: NCT06111794
• Other Study ID Numbers: HT94252310563
• First Posted: Nov 1, 2023
• Last Update Posted: Nov 1, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic

Study Results

No Results Posted as of Nov 1, 2023