A pilot randomised controlled trial of the Spinal Cord Injury and You (SCI&U) online peer health coaching self-management program
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Background
The Spinal Cord Injury and You (SCI&U) intervention aims to improve self-management skills for persons living with SCI using a web-based, peer health-coaching model. This study assessed feasibility of a future definitive trial of SCI&U, specifically feasibility of recruitment and retention, program usability and quality, effect size estimates for self-management outcomes and rehospitalisation rates (i.e. health-related quality of life).
Methods
A two-group, randomised, controlled, pilot trial with prospective recruitment, concealed group allocation, blinded outcome evaluation and waitlist control was conducted. We aimed to recruit 60 adult participants living in the community at least 6 months post-injury who could speak and read English and had a family physician. The intervention included up to 14 1-h online client-coach videoconferencing sessions, goal setting, action planning and a sortable resource library. Data were collected at baseline, 2, 6 and 12 months post-randomisation. SCI&U was offered to waitlist participants at 12 months.
Results
Trial methodology and procedures were feasible. Recruitment and retention targets were achieved. Individuals were randomised to intervention ( n = 31) and waitlist control ( n = 34). Mean time since SCI was 25.6 years (intervention) and 20.2 years (control). Timeline for completion of online sessions was extended from 2 months to 6 months. Outcome data were gathered for 86% (6 months) and 89% (12 months) of participants. Program usability and quality were highly rated on the Mobile App Rating Scale. Difference in Skill and Technique Acquisition subscale between intervention and control was 0.56 (95%CI -0.41, 1.52) at 6 months and 0.72 (95%CI -0.28, 1.72) at 12 months. Other Health Education Impact Questionnaire subscales had large effect sizes: self-monitoring and insight 1.51 (95% CI 0.39, 2.69); emotional distress -1.40 (95%CI -3.04, 0.23). In 12 months post-recruitment, 5 intervention and 4 control participants spent median 11 (95% CI 3-19) and 24 (95% CI 5-95) nights in hospital, respectively.
Conclusions
Trial methodology and procedures were feasible. The SCI&U intervention was acceptable to participants and positively impacted an individual’s ability to self-manage. A definitive trial is warranted to build on these findings, particularly in those with recently acquired SCI. Future recruitment efforts will focus on inpatient rehabilitation hospitals to recruit individuals < 5 years post-injury.
Trial registration
ClinicalTrials.gov, NCT04474171, retrospectively registered 07/13/2020; https://clinicaltrials.gov/study/NCT04474171#study-record-dates .
