Abstract
BackgroundSystemic 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).MethodsThis 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.DiscussionThe 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 registrationClinicalTrials.govNCT04246528. Registered on 27 January 2020
Highlights
Rare diseases, which together affect an estimated 6–8% of people worldwide, are defined as conditions with a prevalence rate fewer than 1 in 2000 [1]
Scleroderma Patient-centered Intervention Network (SPIN) works with partner patient organizations around the world to disseminate its programs free-of-charge
In the planned full-scale randomized controlled trial (RCT), we will evaluate the effect of the SPIN-SELF Program, compared to usual care, on disease management self-efficacy 3 months post-randomization and on self-efficacy 6 months post-randomization and patient activation, social appearance anxiety, and functional health outcomes 3 and 6 months postrandomization
Summary
The SPIN-SELF feasibility trial with progression to fullscale trial will be a pragmatic, two-arm, parallel, partially nested RCT (PN-RCT) [30] with 1:1 randomization to intervention or usual care. Consent forms for the feasibility portion of the trial will explain (1) that the purpose of the feasibility trial is to test the procedures and intervention delivery prior to proceeding to the full-scale trial; (2) that if based on the feasibility trial we determine that no substantive changes are needed to procedures we will proceed directly to the full-scale trial with data from the feasibility study included in the full-scale RCT; and (3) that if substantive changes are required, the feasibility trial data will be analyzed separately from the full-scale trial Consent forms for both the feasibility and full-scale portions will explain that (1) new intervention groups will be started on an approximately monthly basis; (2) each month, enrolled participants with availabilities compatible with scheduled groups will be randomly selected and assigned to an intervention group or care as usual control with 1:1 allocation ratio; (3) participants randomized to the SPIN-SELF intervention group, plus those allocated to care as usual, will complete outcome measures online at 3 and 6 months post-randomization through Qualtrics; (5) depending on availabilities, it is possible that some enrolled participants will not be able to be randomized; and (6) enrolled participants who do not receive the intervention as part of the trial, either because they are selected for the control group or because they are not randomly assigned to either the intervention group or control, will be offered access to the online-only SPIN-SELF Program version after the fullscale trial but will not be placed into videoconference groups.
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