NCT06111794 · University of Virginia
The REACH Intervention for Caregivers of Veterans and Service Members With TBI
(REACH TBI)
What this study is about
This randomly assigned 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-effectiveness, anxiety, depression, and health care frustrations (secondary outcomes).
View original scientific description
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
It assesses caregiver strain in caregivers of individuals with TBI. Values range from 6-30, with higher scores indicating greater strain/worse outcome.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Tampa, Florida
Collaborators
James A. Haley Veterans Administration Hospital, Virginia Commonwealth University, University of Utah, University of Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 9, 2024 · Source of record for eligibility and locations