A Telehealth Transition Assistance Program for Acute Spinal Cord Injury Caregivers: Protocol for a Mixed-Methods, Randomized Clinical Trial (Preprint)

Background: While spinal cord injury (SCI) caregiving can be a rewarding experience, caregivers often experience reduced mental and physical health. Objective: This article describes the methodology of a study examining the efficacy of a newly developed telehealth Transition Assistance Program (TAP) for caregivers of individuals with acute SCI. Methods: A mixed-methods, randomized controlled trial is comparing TAP outcomes to that of a standard-of-care control. The study is recruiting for 48 months and incorporating both quantitative and qualitative outcome measures. Data are collected regarding barriers and facilitators to using the TAP, which might inform dissemination and implementation. Results: This study was funded by the Craig H. Neilsen Foundation in April 2017. It was approved by the institutional review boards at Virginia Commonwealth University and the Hunter Holmes McGuire Veterans Affairs Medical Center that same year. Participant recruitment and data collection began in 2018. Conclusions: This study is implementing and testing an SCI caregiver intervention unlike any created before, targeting a critical time period that, until now, other SCI caregiver interventions have overlooked. Research personnel intend to disseminate the intervention and study findings through the publication of manuscripts and presentations at conferences. If the current study shows improvements in caregiver or patient well-being, the TAP for SCI caregivers could become part of the standard of care for acute SCI. Trial Registration: ClinicalTrials.gov NCT03244098; https://www.clinicaltrials.gov/ct2/show/NCT03244098