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

Abstract

Background The Scleroderma Patient-centered Intervention Network (SPIN) developed an online self-management program (SPIN-SELF) designed to improve disease-management self-efficacy in people with systemic sclerosis (SSc, or scleroderma). The aim of this study was to evaluate feasibility aspects for conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF Program. Methods This feasibility trial was embedded in the SPIN Cohort and utilized the cohort multiple RCT design. In this design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about the trial. Participants in the intervention arm are informed and provide consent, but not the control group. Forty English-speaking SPIN Cohort participants from Canada, the USA, or the UK with low disease-management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale [SEMCD] score ≤ 7) who were interested in using an online self-management program were randomized (3:2 ratio) to be offered the SPIN-SELF Program or usual care for 3 months. Program usage was examined via automated usage logs. User satisfaction was assessed with semi-structured interviews. Trial personnel time requirements and implementation challenges were logged. Results Of 40 SPIN Cohort participants randomized, 26 were allocated to SPIN-SELF and 14 to usual care. Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly, except that two participants with SEMCD scores > 7 (scores of 7.2 and 7.3, respectively) were included, which was caused by a system programming error that rounded SEMCD scores. Of 26 SPIN Cohort participants offered the SPIN-SELF Program, only 9 (35%) consented to use the program. Usage logs showed that use of the SPIN-SELF Program was low: 2 of 9 users (22%) logged into the program only once (median = 3), and 4 of 9 (44%) accessed none or only 1 of the 9 program’s modules (median = 2). Conclusions The results of this study will lead to substantial changes for the planned full-scale RCT of the SPIN-SELF Program that we will incorporate into a planned additional feasibility trial with progression to a full-scale trial. These changes include transitioning to a conventional RCT design with pre-randomization consent and supplementing the online self-help with peer-facilitated videoconference-based groups to enhance engagement. Trial registration clinicaltrials.gov, NCT03914781. Registered 16 April 2019.

Validity and reliability of the Arabic version of the Self-Efficacy for Managing Chronic Disease scale in rheumatoid arthritis patients

“…Self-efficacy is considered now as an important issue in self-care management programs for patients with a chronic illness [ 6 ]. These programs can be presented as online group forms which include different skills for problem solving and provide good contact with healthcare members [ 7 ].…”

Factors Associated with Physical Function among People with Systemic Sclerosis: A Scleroderma Patient-centered Intervention Network (SPIN) Cohort Cross-sectional Study

“…32 Currently, SPIN is conducting a trial to compare the SPIN-SELF program, a self-management program that provides patients with essential knowledge and coping skills to help better manage day-to-day problems in SSc, to usual care. 33 This program combines self-management modules with expert and patient instructions delivered online with support from peer-led groups. 33 Strengths of our study include its large international sample with participants from 53 SPIN sites across 7 countries; the inclusion of a large number of sociodemographic, lifestyle, and physician-assessed disease-related factors in analyses; and the involvement of people with lived SSc experience in the project via leadership in SPIN and participation in the study.…”

Randomized controlled trial of an internet-based self-guided hand exercise program to improve hand function in people with systemic sclerosis: the Scleroderma Patient-centered Intervention Network Hand Exercise Program (SPIN-HAND) trial

“…This suggests that these so-called “signalling items” may not be effective at identifying intervention accepters in advance. We took a similar approach in a recently completed feasibility trial of SPIN’s online self-management program that also enrolled participants through the SPIN Cohort, and results were similar ( N = 40; consent rate 35%) [ 71 ].…”