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 Academic Article uri icon

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abstract

  • 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

authors

  • Nordlund, Julia
  • Henry, Richard S
  • Kwakkenbos, Linda
  • Carrier, Marie-Eve
  • Levis, Brooke
  • Nielson, Warren R
  • Bartlett, Susan J
  • Dyas, Laura
  • Tao, Lydia
  • Fedoruk, Claire
  • Nielsen, Karen
  • Hudson, Marie
  • Pope, Janet
  • Frech, Tracy
  • Gholizadeh, Shadi
  • Johnson, Sindhu R
  • Piotrowski, Pamela
  • Jewett, Lisa R
  • Gordon, Jessica
  • Chung, Lorinda
  • Bilsker, Dan
  • Levis, Alexander W
  • Turner, Kimberly A
  • Cumin, Julie
  • Welling, Joep
  • Fortuné, Catherine
  • Leite, Catarina
  • Gottesman, Karen
  • Sauve, Maureen
  • Rodríguez-Reyna, Tatiana Sofía
  • Larche, Margaret
  • van Breda, Ward
  • Suarez-Almazor, Maria E
  • Wurz, Amanda
  • Culos-Reed, Nicole
  • Malcarne, Vanessa L
  • Mayes, Maureen D
  • Boutron, Isabelle
  • Mouthon, Luc
  • Benedetti, Andrea
  • Thombs, Brett D
  • Riggs, Robert
  • Assassi, Shervin
  • El-Baalbaki, Ghassan
  • Ells, Carolyn
  • van den Ende, Cornelia
  • Fligelstone, Kim
  • Gietzen, Amy
  • Guillot, Geneviève
  • Harel, Daphna
  • Hinchcliff, Monique
  • Nguyen, Christelle
  • Rannou, François
  • Richard, Michelle
  • Schouffoer, Anne A
  • Agard, Christian
  • Abdallah, Nassim Ait
  • Albert, Alexandra
  • André, Marc
  • Bernstein, Elana J
  • Berthier, Sabine
  • Bissonnette, Lyne
  • Bruns, Alessandra
  • Carreira, Patricia
  • Casadevall, Marion
  • Chaigne, Benjamin
  • Correia, Chase
  • Crichi, Benjamin
  • Denton, Christopher
  • Domsic, Robyn
  • Dunne, James V
  • Dunogue, Bertrand
  • Fare, Regina
  • Farge-Bancel, Dominique
  • Fortin, Paul R
  • Granel-Rey, Brigitte
  • Gyger, Genevieve
  • Hachulla, Eric
  • Herrick, Ariane L
  • Hoa, Sabrina
  • Ikic, Alena
  • Jones, Niall
  • Kafaja, Suzanne
  • Khalidi, Nader
  • Lambert, Marc
  • Launay, David
  • Maillard, Hélène
  • Maltez, Nancy
  • Manning, Joanne
  • Marie, Isabelle
  • Martin, Maria
  • Martin, Thierry
  • Masetto, Ariel
  • Maurier, François
  • Mekinian, Arsene
  • Melchor, Sheila
  • Nikpour, Mandana
  • Olagne, Louis
  • Poindron, Vincent
  • Proudman, Susanna
  • Régent, Alexis
  • Rivière, Sébastien
  • Robinson, David
  • Rodriguez, Esther
  • Roux, Sophie
  • Smets, Perrine
  • Sobanski, Vincent
  • Spiera, Robert
  • Steen, Virginia
  • Sutton, Evelyn
  • Thorne, Carter
  • Varga, John
  • Wilcox, Pearce
  • Bourgeault, Angelica
  • Ayala, Mara Cañedo
  • Jiménez, Andrea Carboni
  • Discepola, Marie-Nicole
  • Gagarine, Maria
  • Østbø, Nora

publication date

  • December 2021