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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT06111794
Eligibility Criteria:
Inclusion Criteria:
To be eligible for the study, the participant must:
* identify as a primary caregiver for a V/SM who sustained a TBI at least 6 months prior;
* identify as a primary caregiver who has provided care for a V/SM with TBI for at least 6 months;
* provide some level of daily supervision or assistance with either a physical, cognitive, or behavioral issue they think is likely related to TBI;
* believe that at least half of their caregiving responsibilities are likely related to TBI rather than another health condition(s); and
* endorse a score of at least high burden (a score of 8 or higher) on the Zarit Burden Inventory-4.
Exclusion Criteria:
* no telephone;
* current diagnosis of schizophrenia or other major mental illness;
* auditory impairment that would make telephone use difficult; or
* the caregiver believes that more than half of their caregiving for the V/SM is for issues related to another health condition(s) rather than TBI.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06111794
Study Brief:
Protocol Section:
NCT06111794