@Article{info:doi/10.2196/16799,
author="Carrier, Marie-Eve
and Kwakkenbos, Linda
and Nielson, Warren R
and Fedoruk, Claire
and Nielsen, Karen
and Milette, Katherine
and Pope, Janet
and Frech, Tracy
and Gholizadeh, Shadi
and Hummers, Laura
and Johnson, Sindhu R
and Piotrowski, Pamela
and Jewett, Lisa
and Gordon, Jessica
and Chung, Lorinda
and Bilsker, Dan
and Turner, Kimberly A
and Cumin, Julie
and Welling, Joep
and Fortune, Catherine
and Leite, Catarina
and Gottesman, Karen
and Sauve, Maureen
and Rodr{\'i}guez-Reyna, Tatiana S
and Hudson, Marie
and Larche, Maggie
and van Breda, Ward
and Suarez-Almazor, Maria E
and Bartlett, Susan J
and Malcarne, Vanessa L
and Mayes, Maureen D
and Boutron, Isabelle
and Mouthon, Luc
and Wigley, Fredrick
and Thombs, Brett D",
title="The Scleroderma Patient-Centered Intervention Network Self-Management Program: Protocol for a Randomized Feasibility Trial",
journal="JMIR Res Protoc",
year="2020",
month="Apr",
day="24",
volume="9",
number="4",
pages="e16799",
keywords="feasibility studies; scleroderma, systemic; self-management; trial protocols",
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 (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 ",
issn="1929-0748",
doi="10.2196/16799",
url="http://www.researchprotocols.org/2020/4/e16799/",
url="https://doi.org/10.2196/16799",
url="http://www.ncbi.nlm.nih.gov/pubmed/32329747"
}