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HOME Program for Traumatic Brain Injury (HOME Trial)
N/A
Recruiting
Led By Laraine Winter, PhD
Research Sponsored by Villanova University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
TBI Participant must meet criteria for mild, moderate, or severe TBI
TBI Participant must be English speaking
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four months and ten months
Awards & highlights
HOME Trial Summary
This trial will test an innovative rehabilitation intervention for people with chronic TBI symptoms and their families. The study will look at the effects of the intervention on patients' community reintegration, quality of life, and ability to manage self-identified TBI problems. It will also test the intervention's effects on family caregivers' depressive symptoms, burden, and met family needs.
Who is the study for?
This trial is for individuals with chronic symptoms from a traumatic brain injury (TBI) that occurred over a year ago, and their family members who live with them and are actively involved in their lives. Participants must be adults who speak English and can consent to the study. It's not for those with dementia, recent violence or psychosis, or difficulty understanding interview questions.Check my eligibility
What is being tested?
The HOME Program is being tested; it's an at-home occupational therapy intervention designed to help TBI patients manage symptoms and improve quality of life. Over four months, therapists work with patients and families on strategies tailored to individual needs within the home environment.See study design
What are the potential side effects?
Since this intervention involves non-medical therapeutic activities focused on rehabilitation rather than drugs or surgery, traditional side effects are not expected. However, there may be emotional or psychological impacts as participants adjust to new routines.
HOME Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a traumatic brain injury classified as mild, moderate, or severe.
Select...
I speak English.
Select...
I am 18 years old or older.
HOME Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ four months and ten months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four months and ten months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Caregiver burden scores on the Caregiver Burden subscale of the Caregiver Assessment Scale (CAS) for the family member
Community reintegration (CR) scores on PART-O-17 for the person with TBI
Depressive symptom scores on the CES-D for the family member
+3 moreHOME Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: HOME for UsExperimental Treatment1 Intervention
The HOME intervention is the delivery of an in-home, family inclusive, rehabilitation intervention in eight sessions. Six of the sessions will occur in the home, and two will be over the phone. The in-home sessions will be about 1 ½ hrs. each, and the phone sessions will be about 15 minutes each. The sessions are delivered by an occupational therapist (OT).
Group II: Attention ControlActive Control1 Intervention
The Attention-control condition is the delivery of educational materials over 8 contacts. Three of the contacts are by video conferences or phone calls and last 1 to 2 hours each. Two of the contacts are mailings of educational materials for discussion during the longer sessions. Three of the contacts are phone calls lasting about 10-15 minutes each to check for general updates, health care utilization/access, and study reminders.
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Who is running the clinical trial?
Villanova UniversityLead Sponsor
6 Previous Clinical Trials
2,745 Total Patients Enrolled
Drexel UniversityOTHER
150 Previous Clinical Trials
47,261 Total Patients Enrolled
Thomas Jefferson UniversityOTHER
445 Previous Clinical Trials
145,049 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of recent violence and have experienced a traumatic brain injury.The participant must be living with someone who has a traumatic brain injury (TBI).I am willing and able to give my consent to participate.I have difficulty speaking or understanding language due to a brain injury.My last traumatic brain injury was over a year ago.I have experienced psychosis recently after a brain injury.I have had a traumatic brain injury classified as mild, moderate, or severe.You have been diagnosed with dementia by a doctor or have trouble understanding questions during interviews.You must have a family member who is living with a person with TBI.My family member speaks English.A family member is actively involved in the person's life.I speak English.I am 18 years old or older.I am 18 years or older.
Research Study Groups:
This trial has the following groups:- Group 1: HOME for Us
- Group 2: Attention Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current openings for participation in the trial?
"Yes, according to information on clinicaltrials.gov, this medical trial is accepting participants as of June 7th 2022 since its launch in December 2021. A total of 440 individuals are being recruited at one site for the study."
Answered by AI
How many participants are being observed in this clinical experiment?
"Affirmative. Clinicaltrials.gov displays that this clinical trial, which debuted on December 22nd 2021 is still recruiting patients. 440 participants need to be enrolled at a single site."
Answered by AI
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