By InvitationNot Applicable

BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery)

United States500 participantsStarted 2024-01-26

Plain-language summary

Despite poor outcomes for adults with traumatic brain injury (TBI), there are no U.S. standards for TBI transitional care for patients discharged home from acute hospital care. To enhance the standard of care, we will examine the efficacy of our existing intervention named BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery), a patient- and family-centered TBI transitional care intervention, compared to usual care, among adults with TBI and families. The knowledge generated will drive improvements in outcomes for adults with TBI and families, resulting in improved health of the public.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Patients with TBI, regardless of insurance status, will be eligible if they are/have: * age 18 years or older; * diagnosed with mild, moderate, or severe TBI \[admission Glasgow Coma Scale score of 3-15\]; * admitted to a Duke University Hospital inpatient acute care unit; * plans to be discharged directly home from Duke University Hospital without inpatient rehabilitation or transfer to other settings (community discharge); * sufficient cognitive functioning to participate (i.e., able to follow 2-step commands), as determined by the Galveston Orientation and Amnesia Test (score \>76 eligible); * English- or Spanish-speaking (self-report); * access to a phone or computer with internet capabilities for study participation Patients with TBI will be excluded if they have/are: 1. Pre-injury neurologic conditions/disorder(s): The following neurological conditions/disorders are excluded: • untreated ADHD, cerebral palsy, stroke, multiple sclerosis, Parkinson's disease); pre-injury cognitive impairments (e.g., Alzheimer's disease and related dementias); and developmental disorders (e.g., autism, down's syndrome). The following neurological conditions are not being excluded: • transient ischemic attack, small vessel disease; essential tremor; concussion (maximum 2 prior concussions with no prior history of post-concussion syndrome); myasthenia gravis; dysautonomia; foot drop; degenerative disc disease; spine reticulopathy; bell's palsy + other cranial nerve palsy; …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in patient SF-36 (36-item Short Form Survey) score

Timeframe: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge

Trial details

NCT IDNCT05929833

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-31

View on ClinicalTrials.gov More Traumatic Brain Injury trials