Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 29, 2024
Date Accepted: May 30, 2025
Co-Developing a Novel Intervention to Promote Wellbeing of Family Caregivers of Individuals with Spinal Cord Injury: Research Protocol for a Feasibility Randomized Control Trial
ABSTRACT
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. Burden can have a substantial impact on fcSCI’s wellbeing. 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 burden.
Objective:
The purpose of this study is to evaluate the fidelity of the intervention named COMPANION and its study protocol designed to improve outcomes for fcSCI.
Methods:
A single-site, parallel-group feasibility RCT will be conducted. Participants will be randomized into COMPANION and control groups. The COMPANION group will be given access to the COMPANION e-health module, and control group participants (n = 20 in each group) will be given access to the module after the end of the study. Primary outcome (i.e. caregiver burden) and secondary outcomes (i.e., objective burden, distress, relationship quality, health-related quality of life, competence and caregiving cost) will be measured at baseline, T2 (three months after baseline), and T3 (six months after baseline). Feasibility indicators (e.g. recruitment/retention; educator and participant burden) will be evaluated as binary outcomes against pre-set parameters reflecting viability for a multi-site large-scale RCT. In addition, participants in the COMPANION group will respond to a semi-structured interview to share their feedback regarding using COMPANION.
Results:
As of October 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 refinement of COMPANION. Clinical Trial: ClinicalTrials.gov NCT06364813
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