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.
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.
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.
ClinicalTrials.gov Identifier: NCT03092024.
Post author correction
Article Type: CLINICAL TRIAL PROTOCOL
AuthorsMarie-Eve Carrier, Linda Kwakkenbos, Isabelle Boutron, Joep Welling, Maureen Sauve, Cornelia van den Ende, Anne A. Schouffoer, Marie Hudson, Brett D. Thombs, Luc Mouthon, SPIN Investigators
- • Accepted on 13/09/2017
- • Available online on 16/10/2017
This article is available as full text PDF.
- Carrier, Marie-Eve [PubMed] [Google Scholar] 1
- Kwakkenbos, Linda [PubMed] [Google Scholar] 1, 2, 3
- Boutron, Isabelle [PubMed] [Google Scholar] 4, 5
- Welling, Joep [PubMed] [Google Scholar] 6
- Sauve, Maureen [PubMed] [Google Scholar] 7, 8
- van den Ende, Cornelia [PubMed] [Google Scholar] 9
- Schouffoer, Anne A. [PubMed] [Google Scholar] 10
- Hudson, Marie [PubMed] [Google Scholar] 1, 11
- Thombs, Brett D. [PubMed] [Google Scholar] 1, 2, 11, 12, 13, 14, * Corresponding Author (firstname.lastname@example.org)
- Mouthon, Luc [PubMed] [Google Scholar] 4, 15
- SPIN Investigators *
Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec - Canada
Department of Psychiatry, McGill University, Montreal, Quebec - Canada
Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen - The Netherlands
Université Paris Descartes, Paris - France
Assistance Publique-Hôpitaux de Paris, Paris - France
NVLE Dutch patient organization for systemic autoimmune diseases, Utrecht - The Netherlands
Scleroderma Society of Ontario, Hamilton, Ontario - Canada
Scleroderma Canada, Ottawa, Ontario - Canada
Sint Maartenskliniek, Nijmegen - The Netherlands
Leiden University Medical Center, Leiden - The Netherlands
Department of Medicine, McGill University, Montréal, Québec - Canada
Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montréal, Québec - Canada
Department of Psychology, McGill University, Montréal, Québec - Canada
Department of Educational and Counselling Psychology, McGill University, Montréal, Québec - Canada
Service de Médecine Interne, Hôpital Cochin, Paris - France
The complete list of SPIN investigators is available in the Acknowledgements section.