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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT03450460
Eligibility Criteria:
For Phase 1
Inclusion Criteria
Partner participants, including caregiver Partners,
* Community-based (i.e., no longer participating in a comprehensive rehabilitation program) individuals;
* Have a moderate to severe TBI (Glasgow Coma Scale ≤12) or have cared for (i.e., unpaid) an individual with moderate to severe TBI for at least one year;
* Are 18 years of age or older;
* Have participated in the OBIA Peer Support Program;
* Are fluent in English; and,
* Are able to provide informed consent/have an available proxy who is able to provide informed consent.
Mentor participants -Completed at least one partnership with the OBIA Peer Support Program
Exclusion Criteria
Partner participants, including caregiver Partners,
-Individuals who are medically unstable or have active suicidal ideation
For Phase 2 and 3
Inclusion Criteria
Partner/Mentor participants
* Community-based (i.e., no longer participating in a comprehensive rehabilitation program);
* Have a moderate to severe TBI (Glasgow Coma Scale of 12 or less);
* Are 18 years of age or older;
* Are fluent in English; and,
* Are able to provide informed consent/have an available proxy who is able to provide informed consent.
* Note that Mentor participants may include newly-trained Mentors or Mentors that have already had previous mentorship experience with the OBIA Peer Support Program.
Exclusion Criteria
* Previously participated in the OBIA Peer Support Program or currently receiving peer support/self-management program elsewhere;
* Are medically unstable; and,
* Have active suicidal ideation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03450460
Study Brief:
Protocol Section:
NCT03450460