Caregiver Wellness after Traumatic Brain Injury (CG-Well): Protocol for a randomized clinical trial

Introduction: After injury, survivors of moderate to severe traumatic brain injury (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. The majority of previously developed caregiver and caregiver/survivor dyad interventions after msTBI focus on providing information to either survivors only, or to long-term caregivers, rather than to the new caregiver. This manuscript describes the protocol of an ongoing randomized control trial, Caregiver Wellness after TBI (CG-Well), developed to provide education, support, and skill-building to caregivers of adults with msTBI, beginning when the survivor is early in the clinical course. Methods: Within two weeks of admission to the ICU, participants are randomized to CG-Well online modules (intervention group, n = 50 dyads) or information, support, and referral (ISR) e-bulletins that exist in the public domain (control group, n = 50 dyads) over the first six months after their family member's msTBI. Both groups receive regular phone calls. The primary outcome is intervention satisfaction at six months. Results: Enrollment began in March 2022 and is projected to complete October 2024. We have enrolled approximately 70 % of participants at this time. Primary analysis completion is anticipated April 2025. Discussion: This RCT is designed to evaluate caregiver satisfaction by addressing the need for tailored supportive care for caregivers of msTBI beginning during the ICU admission. Trial registration: Clinicaltrials. gov Registration Number: NCT05307640.