Status:
RECRUITING
Caregiver Wellness After Traumatic Brain Injury (CG-WELL): An Intervention Designed to Promote Well-being in Caregivers of Acute Moderate to Severe Traumatic Brain Injuries
Lead Sponsor:
Natalie Kreitzer
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Trauma, Brain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
After injury, survivors of msTBI depend on informal family caregivers. Upwards of 77% of family caregivers experience poor outcomes, such as adverse life changes, poor health related quality of life, ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Survivor and caregiver ≥18 years old
- Survivor GCS 3-12 after resuscitation
- Survivor \< 2 weeks post injury
- English Speaking - survivor and caregiver
- Exclusion criteria:
- Patient not expected to survive.
- Pregnant - survivor or caregiver
- Prisoner - survivor or caregiver
- History of pre-existing condition that would interfere with follow-up in caregiver or survivor (e.g., substance abuse, alcoholism, end-stage cancers)
- Major prior debilitating neurological or mental health disorder in caregiver or survivor (e.g., schizophrenia, bipolar, stroke, dementia).
Exclusion
Key Trial Info
Start Date :
August 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05307640
Start Date
August 16 2021
End Date
October 1 2025
Last Update
March 26 2025
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267