Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 13, 2019
Date Accepted: Jan 24, 2020
Protocol for a Randomized Feasibility Trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program
ABSTRACT
Background:
Systemic sclerosis (SSc), or scleroderma, is a rare disease that often results in significant disruptions to activities of daily living and can negatively affect physical and psychological well-being. Because there is no known cure, SSc treatment focuses on reducing symptoms and disability and improving health-related quality of life (HRQL). Self-management programs are known to increase self-efficacy for disease management in many chronic diseases. The Scleroderma Patient-centered Intervention Network (SPIN) developed an online self-management program (SPIN-SELF) to increase self-efficacy for disease management and to improve HRQL for SSc patients.
Objective:
The aim of the proposed study is to assess the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF program, by evaluating the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-SELF program.
Methods:
The SPIN-SELF feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with low disease-management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale score ≤ 7) who have indicated interest in using an online self-management program will be randomized with a 3:2 ratio to be offered the SPIN-SELF program or usual care for 3 months.
Results:
Feasibility outcomes include trial implementation processes, required resources and management, scientific aspects, and patient acceptability and usage of the SPIN-SELF program.
Conclusions:
The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQL in patients with SSc. The SPIN-SELF feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-SELF program. Clinical Trial: NCT03914781
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