Wellness program for caregivers of patients with traumatic brain injuries
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
This study tests a wellness program designed to help caregivers of patients with serious brain injuries feel better and manage their challenges more effectively compared to regular support services.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT05307640 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on enhancing the well-being of caregivers who support individuals with moderate to severe traumatic brain injuries (msTBI). It aims to provide education, support, and skill-building for caregivers during the critical period shortly after the injury, particularly during care transitions like ICU discharge. The study will assess the feasibility and satisfaction of the CG-Well program compared to standard information and support services. By addressing the unique challenges faced by new caregivers, the program seeks to improve their health-related quality of life and reduce depressive symptoms.
Who should consider this trial
Good fit: Ideal candidates include English-speaking caregivers and survivors aged 18 and older who are within two weeks post-injury and have a Glasgow Coma Scale score between 3 and 12.
Not a fit: Patients who are not expected to survive, pregnant, prisoners, or have significant pre-existing conditions that could interfere with follow-up will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the mental health and overall well-being of caregivers, leading to better care for patients with traumatic brain injuries.
How similar studies have performed: While previous interventions have focused on long-term caregivers, this approach is novel as it targets new caregivers immediately following the injury.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Cincinnati, Ohio
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Emily Werff
- Email: werffel@ucmail.uc.edu
- Phone: 513-307-2963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.