Co-developing a novel intervention to promote wellbeing of family caregivers of individuals with spinal cord injury: Research protocol

Abstract

AbstractFamily caregivers of individuals with spinal cord injury (fcSCI) are responsible for providing 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. Burden and distress can have a substantial impact on fcSCI’s wellbeing as well as their ability to respond to the needs of the individual with SCI. A direct predictor of fcSCI burden is their appraisal of their ability to cope with the individual with SCI’s illness. Therefore, supporting fcSCI’s access to education relevant to their role and the health and wellbeing of the individual with SCI can help decrease levels of burden. The purpose of this study is to evaluate the fidelity of the intervention named COMPANION and the study protocol for an eHealth approach designed to improve outcomes for fcSCI. COMPANION, co-created with caregiver partners, is an online education program designed to provide accessible education and support for fcSCI. A concurrent mixed methods study including a feasibility randomized controlled trial will be conducted to (i) assess the process, resource, management and treatment indicators; (ii) estimate the parameters needed for a full-scale, multi-site randomized controlled trial and (iii) evaluate the effect that COMPANION has on caregiver clinical outcomes compared to a control group. The primary outcome measured will be fcSCI’s burden in addition to secondary outcomes measuring depression, anxiety, relationship satisfaction, and quality of life. The fcSCI in the intervention group will be given access to COMPANION (at T1) and data will be collected again after three months (T2) and six months (T3) to capture the impact of COMPANION on fcSCI’s psychological wellbeing. Study results will evaluate whether the full study can and should be conducted and will lead to refinement of COMPANION.