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

• Published in: Trials 2021, Vol.22 (1)
• Main Authors: Nordlund, Julia, Henry, Richard S, Kwakkenbos, Linda, Carrier, Marie-Eve, Levis, Brooke, Nielson, Warren R, Bartlett, Susan J, Dyas, Laura, Fedoruk, Claire, Nielsen, Karen, Hudson, Marie, Frech, Tracy, Gholizadeh, Shadi, Johnson, Sindhu R, Piotrowski, Pamela, Jewett, Lisa R, Gordon, Jessica, Chung, Lorinda, Bilsker, Dan, Fortuné, Catherine, Leite, Catarina, Gottesman, Karen, Rodríguez-Reyna, Tatiana Sofía, Larche, Maggie, Suarez-Almazor, Maria E, Wurz, Amanda, Culos-Reed, Nicole, Malcarne, Vanessa L, Mayes, Maureen D, Mouthon, Luc, Benedetti, Andrea, Thombs, Brett D, Riggs, Robert, El-Baalbaki, Ghassan, Ells, Carolyn, van den Ende, Cornelia, Fligelstone, Kim, Gietzen, Amy, Guillot, Geneviève, Hinchcliff, Monique, Nguyen, Christelle, Rannou, François, Richard, Michelle, Schouffoer, Anne A, Agard, Christian, Abdallah, Nassim Ait, André, Marc, Bernstein, Elana J, Berthier, Sabine, Bruns, Alessandra, Casadevall, Marion, Chaigne, Benjamin, Crichi, Benjamin, Denton, Christopher, Domsic, Robyn, Dunne, James V, Dunogue, Bertrand, Fare, Regina, Farge-Bancel, Dominique, Fo, Granel-Rey, Brigitte, Gyger, Genevieve, Hachulla, Eric, Herrick, Ariane L, Hoa, Sabrina, Ikic, Alena, Jones, Niall, Kafaja, Suzanne, Lambert, Marc, Launay, David, Maillard, Hélène, Maltez, Nancy, Manning, Joanne, Marie, Isabelle, Ma, Masetto, Ariel, Maurier, François, Mekinian, Arsene, Melchor, Sheila, Nikpour, Mandana, Poindron, Vincent, Proudman, Susanna, Régent, Alexis, Robinson, David, Rodriguez, Esther, Roux, Sophie, Smets, Perrine, Sobanski, Vincent, Spiera, Robert, Steen, Virginia, Thorne, Carter, Varga, John, Wilcox, Pearce, Bourgeault, Angelica, Ayala, Mara Caéedo, Jiménez, Andrea Carboni, Discepola, Marie-Nicole, Gagarine, Maria, Østba, Nora
• Format: Report
• Language: English
• Subjects: Care and treatment; Development and progression; Diagnosis; Evaluation; Methods; Scleroderma (Disease); Self-management (Psychology); Systemic scleroderma
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-021-05827-z

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 ( 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 Keywords: Scleroderma, Systemic sclerosis, Self-management, Self-efficacy, Patient activation, Randomized controlled trial, e-Health