The scleroderma patient-centered intervention network self-management program: Protocol for a randomized feasibility trial

SPIN Investigators

doi:10.2196/16799

The scleroderma patient-centered intervention network self-management program: Protocol for a randomized feasibility trial

SPIN Investigators

Organizational Psychology

Research output: Contribution to Journal › Article › Academic › peer-review

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.

Original language	English
Article number	e16799
Pages (from-to)	1-15
Number of pages	15
Journal	Journal of Medical Internet Research
Volume	22
Issue number	4
Early online date	24 Apr 2020
DOIs	https://doi.org/10.2196/16799
Publication status	Published - Apr 2020

Funding

The SPIN-SELF program was made possible, thanks to the hard work and dedication of the SPIN Advisory Board members including Catherine Fortune, Scleroderma Society of Ontario, Hamilton, Ontario, Canada; Dominique Godard, Association des Sclérodermiques de France, Sorel-Moussel, France; Karen Gottesman, Scleroderma Foundation, Los Angeles, California, United States; Geneviève Guillot, Sclérodermie Québec, Montreal, Quebec, Canada; Catarina Leite, University of Minho, Braga, Portugal; Karen Nielson, Scleroderma Society of Ontario, Hamilton, Ontario, Canada; Alexandra Portales, Asociación Española de Esclerodermia, Madrid, Spain; Maureen Sauve, Scleroderma Society of Ontario, Hamilton, Ontario, Canada; and Joep Welling, NVLE Dutch patient organization for systemic autoimmune diseases, Utrecht, The Netherlands. Funding for the SPIN-SELF Feasibility trial was provided by the Canadian Institutes of Health Research (TR3-119192; PJT-148504). SPIN has also been funded by grants from the Arthritis Society and The Canadian Institute for Outcomes in Rheumatology Care. In addition, SPIN has received contributions from the Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada, and from McGill University, Montreal, Canada. SPIN has also received support from the Scleroderma Society of Ontario, Scleroderma Canada, Sclérodermie Québec, Scleroderma Manitoba, the Scleroderma Society of Nova Scotia, the Scleroderma Association of British Columbia, and the Scleroderma Association of Saskatchewan. LK was supported by a Canadian Institutes of Health Research Banting Postdoctoral Fellowship. BT was supported by a Fonds de recherche du Québec-Santé researcher salary award. Funders of the SPIN-SELF feasibility trial had no role in the study design or writing and publishing decisions. The SPIN-SELF program was made possible, thanks to the hard work and dedication of the SPIN Advisory Board members including Catherine Fortune, Scleroderma Society of Ontario, Hamilton, Ontario, Canada; Dominique Godard, Association des Scl?rodermiques de France, Sorel-Moussel, France; Karen Gottesman, Scleroderma Foundation, Los Angeles, California, United States; Genevi?ve Guillot, Scl?rodermie Qu?bec, Montreal, Quebec, Canada; Catarina Leite, University of Minho, Braga, Portugal; Karen Nielson, Scleroderma Society of Ontario, Hamilton, Ontario, Canada; Alexandra Portales, Asociaci?n Espa?ola de Esclerodermia, Madrid, Spain; Maureen Sauve, Scleroderma Society of Ontario, Hamilton, Ontario, Canada; and Joep Welling, NVLE Dutch patient organization for systemic autoimmune diseases, Utrecht, The Netherlands. Funding for the SPIN-SELF Feasibility trial was provided by the Canadian Institutes of Health Research (TR3-119192; PJT-148504). SPIN has also been funded by grants from the Arthritis Society and The Canadian Institute for Outcomes in Rheumatology Care. In addition, SPIN has received contributions from the Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada, and from McGill University, Montreal, Canada. SPIN has also received support from the Scleroderma Society of Ontario, Scleroderma Canada, Scl?rodermie Qu?bec, Scleroderma Manitoba, the Scleroderma Society of Nova Scotia, the Scleroderma Association of British Columbia, and the Scleroderma Association of Saskatchewan. LK was supported by a Canadian Institutes of Health Research Banting Postdoctoral Fellowship. BT was supported by a Fonds de recherche du Qu?bec-Sant? researcher salary award. Funders of the SPIN-SELF feasibility trial had no role in the study design or writing and publishing decisions.

Funders	Funder number
Asociaci?n Espa?ola de Esclerodermia
Association des Scl?rodermiques de France
Scleroderma Association of British Columbia
Scleroderma Association of Saskatchewan
Scleroderma Canada
Scleroderma Manitoba
Scleroderma Society of Nova Scotia
Scleroderma Society of Ontario
Sclérodermie Québec
Sorel-Moussel
Scleroderma Foundation
McGill University
Canadian Institutes of Health Research	TR3-119192, PJT-148504
Arthritis Society
Fonds de Recherche du Québec - Santé
Lady Davis Institute for Medical Research
Scleroderma Society of Ontario

Keywords

Feasibility studies
Scleroderma, systemic
Self-management
Trial protocols

Access to Document

10.2196/16799

Persistent URL (handle)

Copy link address

Cite this

@article{4d575372adff4e1387b67561fb21e28d,

title = "The scleroderma patient-centered intervention network self-management program: Protocol for a randomized feasibility trial",

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.",

keywords = "Feasibility studies, Scleroderma, systemic, Self-management, Trial protocols",

author = "Carrier, {Marie Eve} and Linda Kwakkenbos and Nielson, {Warren R.} and Claire Fedoruk and Karen Nielsen and Katherine Milette and Janet Pope and Tracy Frech and Shadi Gholizadeh and Laura Hummers and Johnson, {Sindhu R.} and Pamela Piotrowski and Lisa Jewett and Jessica Gordon and Lorinda Chung and Dan Bilsker and Turner, {Kimberly A.} and Julie Cumin and Joep Welling and Catherine Fortune and Catarina Leite and Karen Gottesman and Maureen Sauve and Rodr{\'i}guez-Reyna, {Tatiana S.} and Marie Hudson and Maggie Larche and {van Breda}, Ward and Suarez-Almazor, {Maria E.} and Bartlett, {Susan J.} and Malcarne, {Vanessa L.} and Mayes, {Maureen D.} and Isabelle Boutron and Luc Mouthon and Fredrick Wigley and Thombs, {Brett D.} and {SPIN Investigators}",

year = "2020",

month = apr,

doi = "10.2196/16799",

language = "English",

volume = "22",

pages = "1--15",

journal = "Journal of Medical Internet Research",

issn = "1438-8871",

publisher = "Journal of medical Internet Research",

number = "4",

}

TY - JOUR

T1 - The scleroderma patient-centered intervention network self-management program

T2 - Protocol for a randomized feasibility trial

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.

AU - SPIN Investigators

PY - 2020/4

Y1 - 2020/4

N2 - 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.

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.

KW - Feasibility studies

KW - Scleroderma, systemic

KW - Self-management

KW - Trial protocols

UR - http://www.scopus.com/inward/record.url?scp=85084396481&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85084396481&partnerID=8YFLogxK

U2 - 10.2196/16799

DO - 10.2196/16799

M3 - Article

AN - SCOPUS:85084396481

SN - 1438-8871

VL - 22

SP - 1

EP - 15

JO - Journal of Medical Internet Research

JF - Journal of Medical Internet Research

IS - 4

M1 - e16799

ER -

The scleroderma patient-centered intervention network self-management program: Protocol for a randomized feasibility trial

Abstract

Funding

Keywords

Access to Document

Persistent URL (handle)

Other files and links

Fingerprint

Cite this