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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06111794
Other study ID # CDMRP-TP220091
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date August 2026

Study information

Verified date May 2024
Source University of Virginia
Contact Paul B Perrin, PhD
Phone 8046476109
Email perrin@virginia.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 110
Est. completion date August 2026
Est. primary completion date August 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


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.

Locations

Country Name City State
United States Tampa VA Medical Center Tampa Florida

Sponsors (5)

Lead Sponsor Collaborator
University of Virginia James A. Haley Veterans Administration Hospital, University of Tennessee, University of Utah, Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Patient-Reported Outcomes Measurement Information System Emotional Distress - Depression - Short Form 4a 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
Secondary Patient-Reported Outcomes Measurement Information System Emotional Distress - Anxiety - Short Form 4a 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
Secondary Patient-Reported Outcomes Measurement Information System - General Self-Efficacy 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
Secondary TBI-CareQOL Health Care Frustration - Self - Short Form 6a 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
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