The REACH Intervention for Caregivers of Veterans and Service Members With TBI
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 Start (Actual) 12 July 2024
🗓️ Primary Completion (Estimated) August 2026
✅ Study Completion (Estimated) August 2026
👥 Enrollment (Estimated) 110
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Tampa, Florida, United States

📋 Eligibility Criteria

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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 26 October 2023
  • First Submitted that Met QC Criteria 26 October 2023
  • First Posted 1 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 July 2024
  • Last Update Posted 16 July 2024
  • Last Verified July 2024