ClinConnect ClinConnect Logo
Search / Trial NCT05117619

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

Launched by VILLANOVA UNIVERSITY · Nov 1, 2021

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Veterans Family Caregiving Rehabilitation Quality Of Life Community Integration

ClinConnect Summary

The HOME Program is a clinical trial designed to help individuals who have had a traumatic brain injury (TBI) for at least a year and their family members. This study aims to improve the quality of life for both the person with TBI and their family by focusing on how their home environment can support daily activities and emotional well-being. Over four months, participants will take part in eight sessions with occupational therapists who will provide guidance on managing TBI symptoms and enhancing family support. This program is unique because it involves both the person with TBI and their family, aiming to create a better living environment that meets their specific needs.

To be eligible for this trial, participants must be at least 18 years old, speak English, and have had a TBI one year or more ago. They should also have a family member who is actively involved in their care and is willing to participate. Participants can expect to learn practical strategies to improve their daily lives and receive support tailored to their situation. Overall, this study aims to better support the growing number of individuals living with TBI and their families, potentially benefiting millions who face these challenges.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria:
  • 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

About Villanova University

Villanova University is a prominent academic institution dedicated to advancing knowledge and innovation through rigorous research and education. As a clinical trial sponsor, Villanova leverages its extensive resources and interdisciplinary expertise to facilitate groundbreaking studies that aim to improve health outcomes and enhance patient care. The university fosters a collaborative environment where faculty and students engage in meaningful research initiatives, ensuring adherence to ethical standards and regulatory compliance. By focusing on impactful clinical trials, Villanova University plays a vital role in contributing to the scientific community and addressing pressing healthcare challenges.

Locations

Villanova, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

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.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials