Protocol for a randomized controlled trial to assess the effect of Self-Management for Amputee Rehabilitation using Technology (SMART): An online self-management program for individuals with lower limb loss

BACKGROUND: Lower limb loss (LLL) is a distressing experience with psychological, physical, and social challenges. Education is needed to enhance the coping skills and confidence of patients to improve LLL outcomes. However, access to rehabilitation services and education is limited outside of urban centers. To address this service gap, we co-created an eHealth platform, called Self-Management for Amputee Rehabilitation using Technology (SMART). OBJECTIVES: First, we will test the effect of SMART and usual care compared with usual care only on walking capacity and confidence among individuals with LLL. Second, we will describe key implementation factors for program delivery and adoption at the person- and provider-level. METHODS: This is a Type 1 Effectiveness-Implementation Hybrid Design, mixed-methods, multi-site (British Columbia and Ontario, Canada), parallel, assessor-blinded randomized controlled trial. Participants will include adults with unilateral LLL, during early prosthetic fitting (<2 years after casting for initial prosthesis). Participants in both groups will receive usual care. The experimental group will receive SMART with weekly support sessions from a trained peer mentor for goal setting and action planning for six weeks. Participants will be encouraged to continue using SMART for an additional four weeks. The control group will receive usual care, and weekly social contacts for six weeks. The primary outcome measure is walking capacity operationalized as the performance based Timed Up and Go test. The secondary outcome is walking confidence using the Ambulatory Self-Confidence Questionnaire. Outcome measures will be assessed at baseline, immediately post-intervention, and four weeks follow-up. We will describe key implementation factors (such as, participant experience, intervention adoption, fidelity) throughout the study using questionnaires, semi-structured interviews, and direct observation. RESULTS: No participants have been enrolled. CONCLUSIONS: SMART has the potential to provide knowledge and skill development to augment rehabilitation outcomes for adults with LLL. TRIAL REGISTRATION: NCT04953364 in Clinical Trial Registry (https://clinicaltrials.gov/).