The HOME Program for Individuals With Traumatic Brain Injury and Family Members

Description

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

Brain Injuries, Traumatic

Study Overview

Study Details

Study overview

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.

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)

The HOME Program for Individuals With Traumatic Brain Injury and Family Members

Condition
Brain Injuries, Traumatic
Intervention / Treatment

-

Contacts and Locations

Villanova

Villanova University, Villanova, Pennsylvania, United States, 19085

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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, 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
  • * 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
  • * None

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Villanova University,

Helene Moriarty, PhD, RN, FAAN, PRINCIPAL_INVESTIGATOR, Villanova University, M. Louise Fitzpatrick College of Nursing and Corporal Michael J. Crescenz VA Medical Ctr.

Laraine Winter, PhD, PRINCIPAL_INVESTIGATOR, Villanova University, M. Louise Fitzpatrick College of Nursing and Corporal Michael J. Crescenz VA Medical Ctr.

Study Record Dates

2026-05-30