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NCT Number: NCT06111794

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Caregiver Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampa VA Medical Center

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Risa Nakase-Richardson, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Paul B Perrin, PhD

CONTACT

[email protected]

(434) 982-2600

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

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

Registry information

Official study title

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

Acronym: REACH TBI

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2023
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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