The HOME Program for Individuals With Traumatic Brain Injury and Family Members
Running, not enrolling · Not applicable
Conditions studied: Brain Injuries, Traumatic
In brief
This purpose of this study is to evaluate an innovative rehabilitation intervention for persons with chronic TBI-related symptoms (1 year or more post injury) and their families. The primary study aims are to 1) test the intervention's effects on patients' community reintegration, quality of life, and ability to manage self-identified TBI problems at the completion of the intervention and 2) test the intervention's effects on family caregivers' depressive symptoms, burden, and met family needs at the completion of the intervention. Based on the person-environment fit framework, HOME (Home-based Occupational-therapy and Management of the Environment) for Us is a 4-month, 8-session intervention delivered by occupational therapists in the home. HOME targets the home environment (physical and social) to realign environmental demands to individual strengths and deficits. HOME engages persons with TBI and family caregivers in strategies to manage chronic TBI symptoms or related difficulties. It educates family members to reinforce and maintain intervention strategies, and addresses family needs. HOME is distinct from standard TBI rehabilitation with respect to who (persons with TBI and families), what (targeting the environment for intervention), when (chronic phase), and where (the home). Patients with chronic TBI symptoms and their family caregivers represent a growing but underserved population. This study has the potential to benefit over 5.3 million persons who live with disabilities from TBI and their family caregivers and to transform the paradigm of care for TBI.
Key facts
- Study ID
- NCT05117619
- Run by
- Villanova University
- People needed
- 281
- Starts
- 2021-12-22
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2026-06-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Villanova University — Villanova, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.