NCT05307640 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
| NCT ID | NCT05307640 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Natalie Kreitzer |
| Condition | Trauma, Brain |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-08-16 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2021-08-16 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, and increased depressive symptoms. Caregivers frequently report minimal support or training to prepare them for their new role. Periods of care transitions, such as ICU discharge, are most difficult. The majority (93%) of previously developed caregiver and caregiver/survivor dyad interventions after msTBI focus on providing information or practical skills to either survivors, or to long-term caregivers (\>6 months post injury), rather than education, support, and skill-building that the new caregiver may use proactively that will benefit the dyad acutely after injury. The Aims of this proposal are to: (1) Determine feasibility, satisfaction, and data trends of CG-Well; and (2) Understand how baseline psychosocial risk factors affect response to CG-Well compared to an Information, Support, and Referral control group. To accomplish this, I will first enroll 6-10 caregivers and tailor CG-well until each finds the intervention acceptable, appropriate, and feasible. I will then enroll 100 (50/group) dyads and determine satisfaction ratings, recruitment, retention, and treatment fidelity of CG-Well. Additionally, I will determine if caregivers report reductions in depressive symptoms and improvements in life changes as a result of improvements in task difficulty and threat appraisal in CG-Well compared to ISR at six months. Information obtained in Aims 1 and 2 will be used to plan a larger Phase III trial of CG-Well. Completing these Aims and the training plan will improve outcomes of caregivers and downstream outcomes of survivors of msTBI, and provide me with the skillset necessary to become an independent researcher who can develop and test high-impact, high-fidelity, sustainable interventions.
Eligibility 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05307640 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Trauma, Brain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05307640 currently recruiting?
Yes, NCT05307640 is actively recruiting participants. Contact the research team at werffel@ucmail.uc.edu for enrollment information.
Where is the NCT05307640 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT05307640 clinical trial?
NCT05307640 is sponsored by Natalie Kreitzer. The trial plans to enroll 100 participants.