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

NCT06111794 | Recruiting

• 1 other identifier: CDMRP-TP220091
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient-Reported Outcomes Measurement Information System Emotional Distress - Depression - Short Form 4a

  Baseline; 3 months (post-intervention); 6 month follow-up

• Patient-Reported Outcomes Measurement Information System Emotional Distress - Anxiety - Short Form 4a

  Baseline; 3 months (post-intervention); 6 month follow-up

• Patient-Reported Outcomes Measurement Information System - General Self-Efficacy

  Baseline; 3 months (post-intervention); 6 month follow-up

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

  Baseline; 3 months (post-intervention); 6 month follow-up

Study Arms (2)

REACH TBI

EXPERIMENTAL

Participants will receive the REACH TBI psychoeducational intervention.

Other: REACH TBI

Waitlist Control

ACTIVE COMPARATOR

Participants will receive the REACH TBI psychoeducational intervention.

Other: REACH TBI

Interventions

REACH TBI OTHER

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.

REACH TBI; Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Tampa VA Medical Center

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Paul B Perrin, PhD

CONTACT

(434) 982-2600; perrin@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Data Science and Psychology

Model Details: This study uses a treatment/waitlist-control crossover repeated-measures design.

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: July 12, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available at the end of data collection and cleaning and will be available for a period of at least 5 years.

Locations

US (1)