Status:
RECRUITING
MENTOR Wellness Program
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute on Disability, Independent Living, and Rehabilitation Research
University of Alabama at Birmingham
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This randomized trial aims to determine the effectiveness a virtual wellness intervention program in individuals with traumatic brain injury (TBI). Participants will be randomized at enrollment into t...
Eligibility Criteria
Inclusion
- Have a medically-documented (e.g., EMS report, hospital record, physician record) or per medical monitor review complicated-mild, moderate, or severe TBI requiring admission to an acute inpatient rehabilitation unit
- Be at least 12 months post-TBI
- Have access to the internet on a computer, tablet, and/or smartphone.
- Speak and understand English or Spanish
- Agree to participate
- Are medically cleared by their primary physician, physiatrist, neurologist, rehabilitation therapist, or other recognized health professional to participate in the study
Exclusion
- No history of complicated-mild, moderate, or severe TBI
- Less than 12 months post-TBI
- In minimally conscious or vegetative state
- Beginning a new treatment regimen (e.g., physical therapy, occupational therapy, vestibular therapy, psychotherapy, and/or medication) at study start that can influence study findings in the judgment of the principal investigator and/or medical monitor (participants whose treatment regimens are stable will be eligible)
- In the judgment of the principal investigator, medical monitor, and/or study team member, presence of significant cognitive impairment (i.e. delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection
- In the judgment of the principal investigator, medical monitor, and/or study team member, significant or major disabling medical condition sufficient to preclude meaningful informed consent and/or data collection
Key Trial Info
Start Date :
April 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT06148324
Start Date
April 11 2024
End Date
August 1 2027
Last Update
March 7 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016