Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT05929833
Eligibility Criteria:
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
4. No family caregiver to participate
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05929833
Study Brief:
Protocol Section:
NCT05929833