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

August 7, 2024 updated by: Paul B. Perrin, University of Virginia

The REACH Intervention for Caregivers of Veterans and Service Members With TBI: Efficacy and Implementation Planning Across the VA Polytrauma System of Care

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Tampa VA Medical Center
        • Contact:
          • Risa Nakase-Richardson, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TBI-CareQOL Caregiver Strain - Short Form 6a
Time Frame: Baseline; 3 months (post-intervention); 6 month follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcomes Measurement Information System Emotional Distress - Depression - Short Form 4a
Time Frame: Baseline; 3 months (post-intervention); 6 month follow-up
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
Patient-Reported Outcomes Measurement Information System Emotional Distress - Anxiety - Short Form 4a
Time Frame: Baseline; 3 months (post-intervention); 6 month follow-up
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
Patient-Reported Outcomes Measurement Information System - General Self-Efficacy
Time Frame: Baseline; 3 months (post-intervention); 6 month follow-up
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
TBI-CareQOL Health Care Frustration - Self - Short Form 6a
Time Frame: Baseline; 3 months (post-intervention); 6 month follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDMRP-TP220091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data are available to other researchers via FITBIR.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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