1. 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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Evelyn Sutton, Lorinda Chung, Sophie Roux, Robert Spiera, Maria E. Suarez-Almazor, Thierry Martin, Shadi Gholizadeh, Carolyn Ells, Isabelle Marie, Louis Olagne, Monique Hinchcliff, Karen Nielsen, Geneviève Guillot, Alena Ikic, Jessica K. Gordon, Christian Agard, Maria Gagarine, Hélène Maillard, Julie Cumin, Angelica Bourgeault, David Robinson, Susanna Proudman, Amy Gietzen, Maureen D. Mayes, François Rannou, Dan Bilsker, Joanne Manning, Richard S. Henry, Ariel Masetto, Isabelle Boutron, Catherine Fortune, Elana J. Bernstein, Carter Thorne, Cornelia H. M. van den Ende, Christopher P. Denton, Sindhu R. Johnson, Regina Fare, Nassim Ait Abdallah, Alexander W. Levis, Maria Martin, Sabrina Hoa, Eric Hachulla, Anne A. Schouffoer, Susan J. Bartlett, Marie Hudson, Sébastien Rivière, Pearce G. Wilcox, Mara Cañedo Ayala, Sheila Melchor, Ariane L. Herrick, Tracy M. Frech, Andrea Benedetti, Laura Dyas, Janet E. Pope, Dominique Farge-Bancel, Andrea Carboni Jiménez, Maggie Larché, Perrine Smets, Vanessa L. Malcarne, Julia Nordlund, Marie-Nicole Discepola, Lyne Bissonnette, Maureen Sauve, Christelle Nguyen, Marion Casadevall, Brett D. Thombs, Karen Gottesman, Patricia Carreira, Marie-Eve Carrier, Sabine Berthier, Mandana Nikpour, Alexandra Albert, Luc Mouthon, Alessandra Bruns, Claire Fedoruk, John Varga, Linda Kwakkenbos, Vincent Poindron, Brooke Levis, Shervin Assassi, Amanda Wurz, Benjamin Crichi, Daphna Harel, Suzanne Kafaja, Esther Rodriguez, Nancy Maltez, Vincent Sobanski, Catarina Leite, Marc André, François Maurier, Ghassan El-Baalbaki, Lisa R. Jewett, Nora Østbø, Marc Lambert, Michelle Richard, James V. Dunne, Niall Jones, Robyn T. Domsic, Kimberly A. Turner, Chase Correia, Joep Welling, Nicole Culos-Reed, Benjamin Chaigne, Kim Fligelstone, Tatiana Sofia Rodriguez-Reyna, Paul R. Fortin, Bertrand Dunogue, Virginia D. Steen, Warren R. Nielson, Ward van Breda, Arsene Mekinian, Nader Khalidi, Brigitte Granel-Rey, David Launay, Pamela Piotrowski, Alexis Régent, Genevieve Gyger, Robert Riggs, Lydia Tao, and Organizational Psychology
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medicine.medical_specialty ,Medicine (General) ,Medicine (miscellaneous) ,law.invention ,Scleroderma ,Experimental Psychopathology and Treatment ,Study Protocol ,03 medical and health sciences ,All institutes and research themes of the Radboud University Medical Center ,0302 clinical medicine ,R5-920 ,Randomized controlled trial ,law ,Patient-Centered Care ,Intervention (counseling) ,Self-management ,Humans ,Medicine ,Pharmacology (medical) ,030212 general & internal medicine ,Disease management (health) ,Randomized Controlled Trials as Topic ,030203 arthritis & rheumatology ,Self-efficacy ,Protocol (science) ,Scleroderma, Systemic ,business.industry ,COVID-19 ,Patient activation ,Women's cancers Radboud Institute for Health Sciences [Radboudumc 17] ,3. Good health ,Cohort ,e-Health ,Physical therapy ,Feasibility Studies ,Anxiety ,Systemic sclerosis ,medicine.symptom ,business - 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.govNCT04246528. Registered on 27 January 2020
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- 2021