TY  - JOUR
AU  - Carrier, Marie-Eve
AU  - Kwakkenbos, Linda
AU  - Nielson, Warren R
AU  - Fedoruk, Claire
AU  - Nielsen, Karen
AU  - Milette, Katherine
AU  - Pope, Janet
AU  - Frech, Tracy
AU  - Gholizadeh, Shadi
AU  - Hummers, Laura
AU  - Johnson, Sindhu R
AU  - Piotrowski, Pamela
AU  - Jewett, Lisa
AU  - Gordon, Jessica
AU  - Chung, Lorinda
AU  - Bilsker, Dan
AU  - Turner, Kimberly A
AU  - Cumin, Julie
AU  - Welling, Joep
AU  - Fortune, Catherine
AU  - Leite, Catarina
AU  - Gottesman, Karen
AU  - Sauve, Maureen
AU  - Rodríguez-Reyna, Tatiana S
AU  - Hudson, Marie
AU  - Larche, Maggie
AU  - van Breda, Ward
AU  - Suarez-Almazor, Maria E
AU  - Bartlett, Susan J
AU  - Malcarne, Vanessa L
AU  - Mayes, Maureen D
AU  - Boutron, Isabelle
AU  - Mouthon, Luc
AU  - Wigley, Fredrick
AU  - Thombs, Brett D
PY  - 2020
DA  - 2020/4/24
TI  - The Scleroderma Patient-Centered Intervention Network Self-Management Program: Protocol for a Randomized Feasibility Trial
JO  - JMIR Res Protoc
SP  - e16799
VL  - 9
IS  - 4
KW  - feasibility studies
KW  - scleroderma, systemic
KW  - self-management
KW  - trial protocols
AB  - 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 
SN  - 1929-0748
UR  - http://www.researchprotocols.org/2020/4/e16799/
UR  - https://doi.org/10.2196/16799
UR  - http://www.ncbi.nlm.nih.gov/pubmed/32329747
DO  - 10.2196/16799
ID  - info:doi/10.2196/16799
ER  -