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

Area of Science:

• Neuroscience
• Rehabilitation Medicine
• Psychology

Background:

• Survivors of moderate to severe traumatic brain injury (msTBI) rely heavily on informal family caregivers.
• A significant majority (upwards of 77%) of these caregivers experience adverse outcomes, including diminished quality of life and increased depressive symptoms.
• Existing interventions often fail to provide timely, targeted support to new caregivers during the critical early stages of recovery.

Purpose of the Study:

• To describe the protocol of the Caregiver Wellness after TBI (CG-Well) randomized control trial.
• To evaluate the effectiveness of a tailored online intervention designed to provide education, support, and skill-building to caregivers of adults with msTBI.
• To assess caregiver satisfaction with the intervention, beginning early in the clinical course after msTBI.

Main Methods:

• This ongoing randomized control trial (RCT) involves dyads of caregivers and survivors of msTBI.
• Participants are randomized within two weeks of ICU admission to either the CG-Well online modules or standard information, support, and referral (ISR) e-bulletins.
• The study's primary outcome is caregiver intervention satisfaction, measured at six months post-randomization. Regular phone calls are provided to both groups.

Main Results:

• Enrollment commenced in March 2022 and is approximately 70% complete, with projected completion in October 2024.
• Primary analysis is anticipated in April 2025.
• The study is actively recruiting and progressing towards its enrollment targets.

Conclusions:

• This RCT addresses the critical need for early, tailored supportive care for caregivers of msTBI survivors.
• The CG-Well intervention aims to enhance caregiver satisfaction and well-being.
• Findings will inform future support strategies for family caregivers in the crucial period following msTBI.