The REACH Intervention for Caregivers of Veterans and Service Members With 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

Overview

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.

Interventions

• 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.

Primary outcome measures

• TBI-CareQOL Caregiver Strain - Short Form 6a [Time frame: Baseline; 3 months (post-intervention); 6 month follow-up]

Secondary outcome measures (4)

• Patient-Reported Outcomes Measurement Information System Emotional Distress - Depression - Short Form 4a [Time frame: 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]
• Patient-Reported Outcomes Measurement Information System - General Self-Efficacy [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Tampa VA Medical Center — Tampa

Identifiers

NCT: NCT06111794 · CDMRP-TP220091

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗