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NCT05117619 · ClinicalTrials.gov registry record · NA
The HOME Program for Individuals With Traumatic Brain Injury and Family Members
A NA study of Brain Injuries, Traumatic, sponsored by Villanova University.
- Recruiting
- Registry status
- NA
- Development phase
- 440
- Enrollment target
- 1
- Study location
NCT05117619: Recruiting NA study of Brain Injuries, Traumatic, sponsored by Villanova University.
NCT05117619 is a NA study of Brain Injuries, Traumatic that is actively recruiting participants, run by Villanova University. The registered enrollment target is 440 participants, above the 235-participant average among 21 other Brain Injuries, Traumatic trials with a reported enrollment target (87% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05117619, a NA study of Brain Injuries, Traumatic, is actively recruiting participants, sponsored by Villanova University.
- RECRUITING
- Registry status
- NA
- Development phase
- 440 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Community reintegration will be measured by the Participation Assessment with Recombined Tools-Objective (PART-O-17). This 17-item tool is an objective measure of social functioning, developed from 3 existing community reintegration measures. It uses 6-point Likert scales from 0 to 5. A mean score is computed. Higher scores indicate greater community reintegration. It will be administered at the Baseline interview (T1), Month 4 interview (T2), and Month 10 interview (T3).
Conditions Studied
Interventions
- BEHAVIORAL HOME for Us
- BEHAVIORAL Attention-control condition
Study Locations (1)
Pennsylvania
- Villanova University - Villanova
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2021-12-22 |
| Est. Completion | 2026-05-30 |
| Phase | NA |
What NCT05117619 shows while recruiting
NCT05117619 is an interventional study that assigns participants to a tested intervention. The registered 440 participants enrollment target is mid-sized for trials with a published cap, above the 235-participant average among 21 other Brain Injuries, Traumatic trials with a reported enrollment target (87% higher).
The record links to 1 condition, with Brain Injuries, Traumatic appearing as the primary indexed condition, and to 2 interventions - of which HOME for Us is the first listed.
NCT05117619 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05117619 about?
NCT05117619 is a clinical study titled "The HOME Program for Individuals With Traumatic Brain Injury and Family Members". 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, a...
What is the current status of trial NCT05117619?
This trial is currently recruiting. It is a NA study. The enrollment target is 440 participants. The study started on 2021-12-22. Estimated completion is 2026-05-30.
What conditions does trial NCT05117619 study?
This clinical trial studies the following conditions: Brain Injuries, Traumatic.
What interventions are being tested in trial NCT05117619?
The interventions under investigation include: HOME for Us (BEHAVIORAL), Attention-control condition (BEHAVIORAL).
Who is sponsoring clinical trial NCT05117619?
This trial is sponsored by Villanova University, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05117619 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05117619's enrollment target sits among peer trials
440 3rd of 21 higher than 19 of 21 other Brain Injuries, Traumatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Injuries, Traumatic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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