Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05117619

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Villanova University

Villanova, Pennsylvania, United States, 19085

Actively Recruiting

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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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