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

Traumatic Brain Injury Clinical Trial

— REACH 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06111794
• Other study ID #: CDMRP-TP220091
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: August 2026

Study information

• Verified date: May 2024
• Source: University of Virginia
• Contact: Paul B Perrin, PhD
• Phone: 8046476109
• Email: perrin[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Caregiver
• Traumatic Brain Injury

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.

Locations

Country	Name	City	State
United States	Tampa VA Medical Center	Tampa	Florida

Sponsors (5)

Lead Sponsor	Collaborator
University of Virginia	James A. Haley Veterans Administration Hospital, University of Tennessee, University of Utah, Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Patient-Reported Outcomes Measurement Information System Emotional Distress - Anxiety - Short Form 4a	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
Secondary	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
Secondary	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