Trials (Nov 2021)

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

  • 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

DOI
https://doi.org/10.1186/s13063-021-05827-z
Journal volume & issue
Vol. 22, no. 1
pp. 1 – 22

Abstract

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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

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