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 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 S.; Larche, Maggie; 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.
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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