Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF)...

Area of Science:

• Rheumatology
• Digital Health Interventions
• Clinical Trial Design

Background:

• Systemic sclerosis (SSc) management requires effective patient support.
• The Scleroderma Patient-centered Intervention Network (SPIN) developed the SPIN-SELF online program to boost self-efficacy.
• Feasibility of a full-scale randomized controlled trial (RCT) for SPIN-SELF was assessed.

Purpose of the Study:

• To evaluate the feasibility of conducting a full-scale RCT for the SPIN-SELF online program.
• To assess recruitment, consent, and engagement metrics for the SPIN-SELF program.

Main Methods:

• A feasibility trial used a cohort multiple RCT design with 40 participants.
• Participants with low self-efficacy (SEMCD score ≤ 7) were randomized (3:2) to SPIN-SELF or usual care.
• Program usage, satisfaction, and implementation challenges were logged.

Main Results:

• Two participants with slightly elevated SEMCD scores were inadvertently included due to a programming error.
• Only 35% (9 of 26) of those offered SPIN-SELF consented to use it.
• Program engagement was low, with 44% accessing only 0-1 of 9 modules.

Conclusions:

• The current design requires significant modification for a full-scale RCT.
• Future trials will use a conventional RCT design with pre-randomization consent.
• Peer-facilitated videoconference groups will supplement the online program to enhance engagement.