The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm...

Area of Science:

• Rheumatology
• Autoimmune Diseases
• Health Services Research

Background:

• Systemic sclerosis (SSc), a rare autoimmune connective tissue disease, presents challenges in patient self-management.
• Previous feasibility trials indicated low uptake for an online self-administered Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program.
• A revised, group-based SPIN-SELF Program incorporating facilitator-led videoconference sessions will be tested in a new feasibility trial.

Purpose of the Study:

• To assess the feasibility of a group-based SPIN-SELF Program for Systemic Sclerosis (SSc) patients.
• To evaluate the revised intervention delivery format for potential progression to a full-scale randomized controlled trial (RCT).
• To determine the effect of the SPIN-SELF Program on disease management self-efficacy and other patient-reported outcomes.

Main Methods:

• A feasibility trial using a two-arm, partially nested RCT design will recruit SSc patients with low to moderate self-efficacy.
• Participants (n=40) will be randomized (1:1) to the group-based SPIN-SELF Program or usual care for 3 months.
• Feasibility will be assessed using pre-defined criteria to determine progression to a full-scale RCT (n=524).

Main Results:

• The primary outcome for the full-scale trial is disease management self-efficacy (SEMCD Scale) at 3 months post-randomization.
• Secondary outcomes include SEMCD scores at 6 months, patient activation, social appearance anxiety, and functional health outcomes at 3 and 6 months.
• Stoppage criteria will guide modifications to trial procedures or the SPIN-SELF Program before initiating the full-scale RCT.

Conclusions:

• The group-based SPIN-SELF Program shows potential for improving disease management self-efficacy in SSc patients.
• The program may also positively impact patient activation, social appearance anxiety, and functional health outcomes.
• SPIN collaborates with international patient organizations to offer its programs freely.