Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND): Study protocol

Abstract

Background: Significant functional impairment of the hands is nearly universal in systemic sclerosis (SSc, scleroderma). Hand exercises may improve hand function, but developing, testing and disseminating rehabilitation interventions in SSc is challenging. The Scleroderma Patient-centered Intervention Network (SPIN) was established to address this issue and has developed an online hand exercise program to improve hand function for SSc patients (SPIN-HAND). The aim of the proposed feasibility trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-HAND intervention. Design and methods: The SPIN-HAND feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with at least mild hand function limitations (Cochin Hand Function Scale ≥3) and an indicated interest in using an online hand-exercise intervention will be randomized with a 1:1 ratio to be offered to use the SPIN-HAND program or usual care for 3 months. The primary aim is to evaluate the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-HAND program. Discussion: The SPIN-HAND exercise program is a self-help tool that may improve hand function in patients with SSc. The SPIN-HAND feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-HAND program. Trial registration: ClinicalTrials.gov Identifier: NCT03092024.

CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration

“…Cohort participants complete outcome measures via the internet upon enrolment and subsequently every 3 months. SPIN Cohort enrollment started in March 2014 and is ongoing.”38…”

“…“Randomization to be offered versus not offered, the SPIN-HAND [Scleroderma Patient-centered Intervention Network hand exercise program] intervention will occur at the time of Cohort participants’ regular SPIN Cohort assessments. Eligible Cohort participants, based on questionnaire responses, will be randomized automatically as they complete their regular SPIN Cohort assessments using a feature in the SPIN Cohort platform, which provides immediate centralized randomization and, thus, complete allocation sequence concealment.”38…”

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

“…Guidance on the appropriate sample size for feasibility trials varies, with rules-of-thumb suggesting 12 to 30 participants or more per trial arm [ 34 , 35 ]. In a previous SPIN feasibility trial of a hand exercises intervention, offer acceptance rate was approximately 60% [ 36 ]. We included a total of 40 SPIN Cohort participants with 3:2 randomization to support additional information needs from intervention arm participants.…”

Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND)

“…SPIN is a collaboration of researchers, clinicians, patient organizations, and people with SSc from Canada, the USA, Europe, Latin America and Australia ( http://www.spinsclero.com ). Over 2,000 SSc patients from 45 centres have been enrolled in SPIN’s web-based cohort, and SPIN investigators are developing a series of online interventions to be tested with SPIN Cohort participants in pragmatic randomized controlled trials (RCTs) ( Kwakkenbos et al, 2013 ; Carrier et al, 2018 ).…”