SPIN Self-Management Feasibility Trial

The SPIN Cohort currently includes over 1800 SSc patients from 41 sites in Canada, the United States, Mexico, Australia, and France, Spain, and the United Kingdom. SPIN Cohort participants complete outcome measures via the Internet upon enrolment and subsequently every three months. SPIN utilizes the cohort multiple RCT (cmRCT) design as a framework for conducting trials of interventions. SPIN Cohort participants consent to allow personal data to be used for observational research, to assess intervention trial eligibility and, if eligible, to be randomized. Participants also consent that, if eligible and randomized to usual care, the participants' data can be used to evaluate intervention effectiveness without the participants being notified that they have been randomized to the usual care group and not offered the intervention. Thus, in SPIN trials, trial status is masked for participants in the control arm, who are not aware that they are participating in the trial, but not for participants in the intervention arm. The investigative team does not interact with patients for care provision or outcome assessment, which are done automatically via the internet. The SPIN‐SELF feasibility study is embedded in the SPIN Cohort and will evaluate the feasibility of conducting a full‐scale RCT of the SPIN‐SELF Program. Investigators will randomize 40 SPIN Cohort participants with low disease management self‐efficacy and an indicated interest in using an online self‐management program to be offered the SPIN‐SELF Program or usual care only. Randomization will occur at the time of participants' regular SPIN Cohort assessments. Eligible participants, based on questionnaire responses, will be randomized automatically using simple 3:2 randomization, using a feature in the SPIN Cohort platform, which provides immediate randomization and complete allocation sequence concealment. Feasibility outcomes include participant eligibility and recruitment, and numbers and percentages of participants who do not respond to follow‐up measures. Use of the online intervention will be described by presenting the frequency of logins and time spent on the SPIN‐SELF Program. Analysis of outcome measures will include the completeness of data and presence of floor or ceiling effects. Descriptive statistics will be used to provide means and standard deviations for the measures. Qualitative information and information related to management and usability of the SPIN‐SELF Program will inform any necessary changes to the intervention or trial procedures.