Actively Recruiting
The HOME Program for Individuals With Traumatic Brain Injury and Family Members
Led by Villanova University · Updated on 2024-05-31
440
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
Sponsors
V
Villanova University
Lead Sponsor
U
University of Pennsylvania
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The HOME Program for Individuals With Traumatic Brain Injury and Family Members
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English speaking
- 18 years or older
- Most recent traumatic brain injury at least 1 year ago
- Has participating family member living with person with TBI
- Willing and able to provide informed consent
- Meets criteria for mild, moderate, or severe traumatic brain injury
- Acknowledges TBI-related symptoms at screening
- Family member is a partner, family member, or significant other
- Family member lives with person with TBI
- Family member is 18 years or older
- Family member is actively involved in person's life
- Family member is English speaking
- Family member is willing and able to provide informed consent
You will not qualify if you...
- Dementia diagnosed by a physician or participant has difficulty understanding interview questions
- History of recent violence
- Aphasia
- Recent psychosis
- No exclusion criteria for family members
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Villanova University
Villanova, Pennsylvania, United States, 19085
Actively Recruiting
Research Team
J
Jan Dinella, B.S.
CONTACT
H
Helene Moriarty, PhD, RN, FAAN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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