New program aims to improve life after brain injury
NCT ID NCT05929833
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a program called BETTER that helps adults with traumatic brain injury and their families after they leave the hospital. The program provides education, training, and therapy to support recovery at home. Researchers will compare the program to usual care in 500 participants to see if it improves quality of life and thinking skills.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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; neurogenic bladder (if in isolation); and epilepsy \[patients with epilepsy are eligible to participate if they had no hospital admissions or emergency department visit for seizures in the last 6 months\] 2. Severe psychiatric diagnosis (i.e., untreated schizophrenia, untreated bipolar 1 or 2, any indication of psychosis or acute psychotic events occurring) that are untreated with no psychiatric provider on record, which would preclude patients from having capacity to consent 3. Admitted from settings or locations other than home Family members will include patient-identified biological relatives and friends and are eligible if they are/have: * associated with a patient meets all above-listed patient criteria; * age 18 years or older; * an anticipated primary caregiver after discharge (i.e., plans to live in same home as patient or have direct contact with patient \>10 hours/week); * English- or Spanish-speaking (self-report); * access to a phone or computer with internet capabilities for study participation. Family members will be excluded if the associated patient is not eligible or declines participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Duke University Hospital
Durham, North Carolina, 27710, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can group wellness classes improve life after brain injury or dementia?
- Can a web program rebuild memory after brain injury?
- Why a simple fall can cause brain bleeding in older adults
- Bedside ultrasound could flag hidden brain injury decline
- Zapping the brain to restore lost vision
- Machine learning may forecast brain decline after head injury