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
Creators: name: Nordlund, Julia
name: Henry, Richard S.
name: Kwakkenbos, Linda
name: Carrier, Marie-Eve
name: Levis, Brooke
name: Nielson, Warren R.
name: Bartlett, Susan J.
name: Dyas, Laura
name: Tao, Lydia
name: Fedoruk, Claire
name: Nielsen, Karen
name: Hudson, Marie
name: Pope, Janet
name: Frech, Tracy
name: Gholizadeh, Shadi
name: Johnson, Sindhu R.
name: Piotrowski, Pamela
name: Jewett, Lisa R.
name: Gordon, Jessica
name: Chung, Lorinda
name: Bilsker, Dan
name: Levis, Alexander W.
name: Turner, Kimberly A.
name: Cumin, Julie
name: Welling, Joep
name: Fortuné, Catherine
name: Leite, Catarina
name: Gottesman, Karen
name: Sauve, Maureen
name: Rodríguez-Reyna, Tatiana S.
name: Larche, Maggie
name: Van Breda, Ward
name: Suarez-Almazor, Maria E.
name: Wurz, Amanda
name: Culos-Reed, Nicole
name: Malcarne, Vanessa L.
name: Mayes, Maureen D.
name: Boutron, Isabelle
name: Mouthon, Luc
name: Benedetti, Andrea
name: Thombs, Brett D.
Publisher: name: BioMed Central
Year: 2021

description: 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