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

Linda Kwakkenbos¹, Nora Østbø², Marie-Eve Carrier²

¹Department of Clinical Psychology, Radboud University, Montessorilaan 3, 6525, HR, Nijmegen, The Netherlands. kwakkenbosl@gmail.com.

Pilot and Feasibility Studies

|February 27, 2022

Summary

This study evaluated an online self-management program for scleroderma (systemic sclerosis, SSc). Low engagement suggests modifications are needed before a full trial, including adding peer support.

Keywords:

Cohort multiple RCT Feasibility trial Internet intervention Scleroderma Self-management Systemic sclerosis

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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.