The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial

Abstract Background Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. We completed an initial feasibility trial of an online self-administered version of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program using the cohort mul...

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Autores principales:	Julia Nordlund, Richard S. Henry, Linda Kwakkenbos, Marie-Eve Carrier, Brooke Levis, Warren R. Nielson, Susan J. Bartlett, Laura Dyas, Lydia Tao, Claire Fedoruk, Karen Nielsen, Marie Hudson, Janet Pope, Tracy Frech, Shadi Gholizadeh, Sindhu R. Johnson, Pamela Piotrowski, Lisa R. Jewett, Jessica Gordon, Lorinda Chung, Dan Bilsker, Alexander W. Levis, Kimberly A. Turner, Julie Cumin, Joep Welling, Catherine Fortuné, Catarina Leite, Karen Gottesman, Maureen Sauve, Tatiana Sofía Rodríguez-Reyna, Maggie Larche, Ward van Breda, Maria E. Suarez-Almazor, Amanda Wurz, Nicole Culos-Reed, Vanessa L. Malcarne, Maureen D. Mayes, Isabelle Boutron, Luc Mouthon, Andrea Benedetti, Brett D. Thombs, on behalf of the SPIN Investigators
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Scleroderma Systemic sclerosis Self-management Self-efficacy Patient activation Randomized controlled trial Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/1357d21853f5484f8f43ccef5c8ce654
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spelling	oai:doaj.org-article:1357d21853f5484f8f43ccef5c8ce6542021-11-28T12:28:27ZThe Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial10.1186/s13063-021-05827-z1745-6215https://doaj.org/article/1357d21853f5484f8f43ccef5c8ce6542021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05827-zhttps://doaj.org/toc/1745-6215Abstract Background Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. We completed an initial feasibility trial of an online self-administered version of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program using the cohort multiple randomized controlled trial (RCT) design. Due to low intervention offer uptake, we will conduct a new feasibility trial with progression to full-scale trial, using a two-arm parallel, partially nested RCT design. The SPIN-SELF Program has also been revised to include facilitator-led videoconference group sessions in addition to online material. We will test the group-based intervention delivery format, then evaluate the effect of the SPIN-SELF Program on disease management self-efficacy (primary) and patient activation, social appearance anxiety, and functional health outcomes (secondary). Methods This study is a feasibility trial with progression to full-scale RCT, pending meeting pre-defined criteria, of the SPIN-SELF Program. Participants will be recruited from the ongoing SPIN Cohort ( http://www.spinsclero.com/en/cohort ) and via social media and partner patient organizations. Eligible participants must have SSc and low to moderate disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) Scale score ≤ 7.0). Participants will be randomized (1:1 allocation) to the group-based SPIN-SELF Program or usual care for 3 months. The primary outcome in the full-scale trial will be disease management self-efficacy based on SEMCD Scale scores at 3 months post-randomization. Secondary outcomes include SEMCD scores 6 months post-randomization plus patient activation, social appearance anxiety, and functional health outcomes at 3 and 6 months post-randomization. We will include 40 participants to assess feasibility. At the end of the feasibility portion, stoppage criteria will be used to determine if the trial procedures or SPIN-SELF Program need important modifications, thereby requiring a re-set for the full-scale trial. Otherwise, the full-scale RCT will proceed, and outcome data from the feasibility portion will be utilized in the full-scale trial. In the full-scale RCT, 524 participants will be recruited. Discussion The SPIN-SELF Program may improve disease management self-efficacy, patient activation, social appearance anxiety, and functional health outcomes in people with SSc. SPIN works with partner patient organizations around the world to disseminate its programs free-of-charge. Trial registration ClinicalTrials.gov NCT04246528 . Registered on 27 January 2020Julia NordlundRichard S. HenryLinda KwakkenbosMarie-Eve CarrierBrooke LevisWarren R. NielsonSusan J. BartlettLaura DyasLydia TaoClaire FedorukKaren NielsenMarie HudsonJanet PopeTracy FrechShadi GholizadehSindhu R. JohnsonPamela PiotrowskiLisa R. JewettJessica GordonLorinda ChungDan BilskerAlexander W. LevisKimberly A. TurnerJulie CuminJoep WellingCatherine FortunéCatarina LeiteKaren GottesmanMaureen SauveTatiana Sofía Rodríguez-ReynaMaggie LarcheWard van BredaMaria E. Suarez-AlmazorAmanda WurzNicole Culos-ReedVanessa L. MalcarneMaureen D. MayesIsabelle BoutronLuc MouthonAndrea BenedettiBrett D. Thombson behalf of the SPIN InvestigatorsBMCarticleSclerodermaSystemic sclerosisSelf-managementSelf-efficacyPatient activationRandomized controlled trialMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-22 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Scleroderma Systemic sclerosis Self-management Self-efficacy Patient activation Randomized controlled trial Medicine (General) R5-920
spellingShingle	Scleroderma Systemic sclerosis Self-management Self-efficacy Patient activation Randomized controlled trial Medicine (General) R5-920 Julia Nordlund Richard S. Henry Linda Kwakkenbos Marie-Eve Carrier Brooke Levis Warren R. Nielson Susan J. Bartlett Laura Dyas Lydia Tao Claire Fedoruk Karen Nielsen Marie Hudson Janet Pope Tracy Frech Shadi Gholizadeh Sindhu R. Johnson Pamela Piotrowski Lisa R. Jewett Jessica Gordon Lorinda Chung Dan Bilsker Alexander W. Levis Kimberly A. Turner Julie Cumin Joep Welling Catherine Fortuné Catarina Leite Karen Gottesman Maureen Sauve Tatiana Sofía Rodríguez-Reyna Maggie Larche Ward van Breda Maria E. Suarez-Almazor Amanda Wurz Nicole Culos-Reed Vanessa L. Malcarne Maureen D. Mayes Isabelle Boutron Luc Mouthon Andrea Benedetti Brett D. Thombs on behalf of the SPIN Investigators The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial
description	Abstract Background Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. We completed an initial feasibility trial of an online self-administered version of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program using the cohort multiple randomized controlled trial (RCT) design. Due to low intervention offer uptake, we will conduct a new feasibility trial with progression to full-scale trial, using a two-arm parallel, partially nested RCT design. The SPIN-SELF Program has also been revised to include facilitator-led videoconference group sessions in addition to online material. We will test the group-based intervention delivery format, then evaluate the effect of the SPIN-SELF Program on disease management self-efficacy (primary) and patient activation, social appearance anxiety, and functional health outcomes (secondary). Methods This study is a feasibility trial with progression to full-scale RCT, pending meeting pre-defined criteria, of the SPIN-SELF Program. Participants will be recruited from the ongoing SPIN Cohort ( http://www.spinsclero.com/en/cohort ) and via social media and partner patient organizations. Eligible participants must have SSc and low to moderate disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) Scale score ≤ 7.0). Participants will be randomized (1:1 allocation) to the group-based SPIN-SELF Program or usual care for 3 months. The primary outcome in the full-scale trial will be disease management self-efficacy based on SEMCD Scale scores at 3 months post-randomization. Secondary outcomes include SEMCD scores 6 months post-randomization plus patient activation, social appearance anxiety, and functional health outcomes at 3 and 6 months post-randomization. We will include 40 participants to assess feasibility. At the end of the feasibility portion, stoppage criteria will be used to determine if the trial procedures or SPIN-SELF Program need important modifications, thereby requiring a re-set for the full-scale trial. Otherwise, the full-scale RCT will proceed, and outcome data from the feasibility portion will be utilized in the full-scale trial. In the full-scale RCT, 524 participants will be recruited. Discussion The SPIN-SELF Program may improve disease management self-efficacy, patient activation, social appearance anxiety, and functional health outcomes in people with SSc. SPIN works with partner patient organizations around the world to disseminate its programs free-of-charge. Trial registration ClinicalTrials.gov NCT04246528 . Registered on 27 January 2020
format	article
author	Julia Nordlund Richard S. Henry Linda Kwakkenbos Marie-Eve Carrier Brooke Levis Warren R. Nielson Susan J. Bartlett Laura Dyas Lydia Tao Claire Fedoruk Karen Nielsen Marie Hudson Janet Pope Tracy Frech Shadi Gholizadeh Sindhu R. Johnson Pamela Piotrowski Lisa R. Jewett Jessica Gordon Lorinda Chung Dan Bilsker Alexander W. Levis Kimberly A. Turner Julie Cumin Joep Welling Catherine Fortuné Catarina Leite Karen Gottesman Maureen Sauve Tatiana Sofía Rodríguez-Reyna Maggie Larche Ward van Breda Maria E. Suarez-Almazor Amanda Wurz Nicole Culos-Reed Vanessa L. Malcarne Maureen D. Mayes Isabelle Boutron Luc Mouthon Andrea Benedetti Brett D. Thombs on behalf of the SPIN Investigators
author_facet	Julia Nordlund Richard S. Henry Linda Kwakkenbos Marie-Eve Carrier Brooke Levis Warren R. Nielson Susan J. Bartlett Laura Dyas Lydia Tao Claire Fedoruk Karen Nielsen Marie Hudson Janet Pope Tracy Frech Shadi Gholizadeh Sindhu R. Johnson Pamela Piotrowski Lisa R. Jewett Jessica Gordon Lorinda Chung Dan Bilsker Alexander W. Levis Kimberly A. Turner Julie Cumin Joep Welling Catherine Fortuné Catarina Leite Karen Gottesman Maureen Sauve Tatiana Sofía Rodríguez-Reyna Maggie Larche Ward van Breda Maria E. Suarez-Almazor Amanda Wurz Nicole Culos-Reed Vanessa L. Malcarne Maureen D. Mayes Isabelle Boutron Luc Mouthon Andrea Benedetti Brett D. Thombs on behalf of the SPIN Investigators
author_sort	Julia Nordlund
title	The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial
title_short	The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial
title_full	The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial
title_fullStr	The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial
title_full_unstemmed	The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial
title_sort	scleroderma patient-centered intervention network self-management (spin-self) program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/1357d21853f5484f8f43ccef5c8ce654
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The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial

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