Codeveloping a Novel Intervention to Promote the Well-Being of Family Caregivers of Individuals With Spinal Cord Injury: Protocol for a Feasibility Randomized Control Trial

Background Family caregivers of individuals with spinal cord injury (fcSCI) provide assistance with activities of daily living for individuals with spinal cord injury (SCI), which can include emotional support and physical assistance. Over time, providing daily support can put fcSCI at risk of experiencing caregiver burden. This burden can have a substantial impact on fcSCI’s well-being. A direct predictor of the fcSCI burden is their appraisal of their ability to cope with the individual with SCI. Therefore, supporting fcSCI’s access to education relevant to their role and the health and well-being of the individual with SCI can help decrease this burden. Objective The purpose of this study is to evaluate the fidelity of the COMPANION intervention and its study protocol designed to improve outcomes for fcSCI. Methods Recruitment began in June 2024 and is ongoing. Data collection was completed in April 2025. The fcSCI randomized into the intervention group have been given access to COMPANION after randomization. Data collection for both participant groups (COMPANION and control) will be performed after randomization and will be performed again after 3 months (T2) and 6 months (T3) to capture the impact of COMPANION on fcSCI’s psychological well-being. Results As of June 2024, recruitment has begun and is ongoing. Data collection has begun and will conclude in 2025. The fcSCI randomized into the intervention group have been given access to COMPANION after randomization. Data collection for both participant groups (COMPANION and control) is collected after randomization, and again after three months (T2) and six months (T3) to capture the impact of COMPANION on fcSCI’s psychological wellbeing. Conclusions Study results will evaluate whether the full study can and should be conducted and will lead to the refinement of COMPANION. Trial Registration ClinicalTrials.gov NCT06364813; https://clinicaltrials.gov/study/NCT06364813 International Registered Report Identifier (IRRID) DERR1-10.2196/67709