RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2021-12-22
Study Completion:2026-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05117619

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English speaking
  2. * 18 years or older
  3. * Most recent TBI at least 1 year ago
  4. * Has participating family member living with person with TBI
  5. * Willing/able to provide informed consent
  6. * Meets criteria for mild, moderate, or severe TBI
  7. * Acknowledges TBI-related symptoms at screening
  8. * Family member, partner, or significant other
  9. * Living with person with TBI
  10. * 18 years or older
  11. * Actively involved in the person's life
  12. * English speaking
  13. * Willing/able to provide informed consent
  1. * Dementia based on (a) physician diagnosis of dementia and/or (b) participant's difficulty in comprehending interview questions
  2. * History of recent violence
  3. * Aphasia
  4. * Recent psychosis
  5. * None

Contacts and Locations

Study Contact

Jan Dinella, B.S.
CONTACT
610-519-4504
Janet.dinnella@villanova.edu
Helene Moriarty, PhD, RN, FAAN
CONTACT
610-519-5735
Helene.moriarty@villanova.edu

Principal Investigator

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 Locations (Sites)

Villanova University
Villanova, Pennsylvania, 19085
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-22
Study Completion Date2026-05-30

Study Record Updates

Study Start Date2021-12-22
Study Completion Date2026-05-30

Terms related to this study

Keywords Provided by Researchers

  • Veterans
  • Family Caregiving
  • Rehabilitation
  • Quality of Life
  • Community Integration

Additional Relevant MeSH Terms

  • Brain Injuries, Traumatic