The Scleroderma Patient-Centered Intervention Network Self-Management Program: Protocol for a Randomized Feasibility Trial
Authors: Carrier Marie-Eve , Kwakkenbos Linda , Nielson Warren R , Fedoruk Claire , Nielsen Karen , Milette Katherine , Pope Janet , Frech Tracy , Gholizadeh Shadi , Hummers Laura , Johnson Sindhu R , Piotrowski Pamela , Jewett Lisa , Gordon Jessica , Chung Lorinda , Bilsker Dan , Turner Kimberly A , Cumin Julie , Welling Joep , Fortune Catherine , Leite Catarina , Gottesman Karen , Sauve Maureen , Rodríguez-Reyna Tatiana S , Hudson Marie , Larche Maggie , van Breda Ward , Suarez-Almazor Maria E , Bartlett Susan J , Malcarne Vanessa L , Mayes Maureen D , Boutron Isabelle , Mouthon Luc , Wigley Fredrick , Thombs Brett D ,   SPIN Investigators
Published: January 2020

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 (HRQoL). Self-management programs are known to increase self-efficacy for disease management in many chronic diseases. The Scleroderma Patient-centered Intervention Network (SPIN) developed a Web-based self-management program (SPIN self-management; SPIN-SELF) to increase self-efficacy for disease management and to improve HRQoL for patients with SSc.

Objective
The proposed study aims 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 a Web-based self-management program, will be randomized with a 3:2 ratio into the SPIN-SELF program or usual care for 3 months. Feasibility outcomes include trial implementation processes, required resources and management, scientific aspects, and patient acceptability and usage of the SPIN-SELF program.

Results
Enrollment of the 40 participants occurred between July 5, 2019, and July 27, 2019. By November 25, 2019, data collection of trial outcomes was completed. Data analysis is underway, and results are expected to be published in 2020.

Conclusions
The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL 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.

International Registered Report Identifier (IRRID)
DERR1-10.2196/16799