A program to help individuals with traumatic brain injury and their families
A Randomized Controlled Trial of an Innovative In-home Rehabilitation Program for Persons With TBI and Their Families: Home-based Occupational-therapy and Management of the Environment (HOME for Us)
This study is testing a new home program to help people with long-term symptoms from traumatic brain injury and their families improve their quality of life and support each other better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Villanova University Academic / other |
| Locations | 1 site (Villanova, Pennsylvania) |
| Trial ID | NCT05117619 on ClinicalTrials.gov |
What this trial studies
This study evaluates an innovative rehabilitation intervention called HOME for Us, designed for individuals with chronic symptoms from traumatic brain injury (TBI) and their family members. The program consists of 8 home-based sessions delivered by occupational therapists over four months, focusing on improving community reintegration and quality of life for TBI patients while also addressing the needs of family caregivers. By targeting the home environment and engaging both patients and caregivers, the intervention aims to manage chronic TBI symptoms and reduce caregiver burden. The study will assess the effectiveness of this approach in enhancing the overall well-being of both patients and their families.
Who should consider this trial
Good fit: Ideal candidates include English-speaking adults aged 18 and older who have experienced a TBI at least one year prior and have a family member living with them who is actively involved in their care.
Not a fit: Patients with dementia, recent violence history, or severe communication difficulties such as aphasia may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and community integration for individuals with chronic TBI symptoms and reduce caregiver stress.
How similar studies have performed: While there is limited research on home-based interventions for chronic TBI symptoms, similar approaches have shown promise in enhancing rehabilitation outcomes in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: TBI Participant: * English speaking * 18 years or older * Most recent TBI at least 1 year ago * Has participating family member living with person with TBI * Willing/able to provide informed consent * Meets criteria for mild, moderate, or severe TBI * Acknowledges TBI-related symptoms at screening Family Member * Family member, partner, or significant other * Living with person with TBI * 18 years or older * Actively involved in the person's life * English speaking * Willing/able to provide informed consent Exclusion Criteria: TBI Participant: * Dementia based on (a) physician diagnosis of dementia and/or (b) participant's difficulty in comprehending interview questions * History of recent violence * Aphasia * Recent psychosis Family Member * None
Where this trial is running
Villanova, Pennsylvania
- Villanova University — Villanova, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Helene Moriarty, PhD, RN, FAAN — Villanova University, M. Louise Fitzpatrick College of Nursing and Corporal Michael J. Crescenz VA Medical Ctr.
- Study coordinator: Jan Dinella, B.S.
- Email: Janet.dinnella@villanova.edu
- Phone: 610-519-4504
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.