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
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 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. ,   on behalf of the SPIN Investigators, 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 
Published: November 2021

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