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
Trials, vol. 23, pp. 994
Abstract
BACKGROUND: Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. Functional impairment of hands is common. The Scleroderma Patient-centered Intervention Network (SPIN)-HAND trial compared effects of offering access to an online self-guided hand exercise program to usual care on hand function (primary) and functional health outcomes (secondary) in people with SSc with at least mild hand function limitations. METHODS: The pragmatic, two-arm, parallel-group cohort multiple randomized controlled trial was embedded in the SPIN Cohort. Cohort participants with Cochin Hand Function Scale (CHFS) scores ≥ 3 and who indicated interest in using the SPIN-HAND Program were randomized (3:2 ratio) to an offer of program access or to usual care (targeted N = 586). The SPIN-HAND program consists of 4 modules that address (1) thumb flexibility and strength; (2) finger bending; (3) finger extension; and (4) wrist flexibility and strength. The primary outcome analysis compared CHFS scores 3 months post-randomization between participants offered versus not offered the program. Secondary outcomes were CHFS scores 6 months post-randomization and functional health outcomes (Patient-Reported Outcomes Measurement Information System profile version 2.0 domain scores) 3 and 6 months post-randomization. RESULTS: In total, 466 participants were randomized to intervention offer (N = 280) or usual care (N = 186). Of 280 participants offered the intervention, 170 (61%) consented to access the program. Of these, 117 (69%) viewed at least one hand exercise instruction video and 77 (45%) logged into the program website at least 3 times. In intent-to-treat analyses, CHFS scores were 1.2 points lower (95% CI - 2.8 to 0.3) for intervention compared to usual care 3 months post-randomization and 0.1 points lower (95% CI - 1.8 to 1.6 points) 6 months post-randomization. There were no statistically significant differences in other outcomes. CONCLUSION: The offer to use the SPIN-HAND Program did not improve hand function. Low offer uptake, program access, and minimal usage among those who accessed the program limited our ability to determine if using the program would improve function. To improve engagement, the program could be tested in a group format or as a resource to support care provided by a physical or occupational therapist. TRIAL REGISTRATION: NCT03419208 . Registered on February 1, 2018.
Authors 95
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Radboud University Nijmegen · Radboud University Medical Center · Radboud Institute for Health Sciences
Affiliation as printed
Clinical Psychology, Radboud University, Nijmegen, The Netherlands
Department of Medical Psychology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands
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Jewish General Hospital · Lady Davis Institute for Medical Research
Affiliation as printed
Lady Davis Institute for Medical Research of the Jewish General Hospital, 3755 Cote Ste Catherine Road, Montreal, QC, H3T 1E2, Canada
Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada
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Affiliation as printed
NVLE Dutch Patient Organization for Systemic Autoimmune Diseases, Utrecht, The Netherlands
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Jewish General Hospital · Lady Davis Institute for Medical Research · Keele University
Affiliation as printed
Centre for Prognosis Research, School of Medicine, Keele University, Staffordshire, UK
Lady Davis Institute for Medical Research of the Jewish General Hospital, 3755 Cote Ste Catherine Road, Montreal, QC, H3T 1E2, Canada
Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada
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Affiliation as printed
Department of Biostatistics, Harvard T. H. Chan School of Public Health, Cambridge, MA, USA
Department of Biostatistics, Harvard T. H. Chan School of Public Health, Cambridge, USA
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Scleroderma Society of Ontario
Affiliation as printed
Scleroderma Canada, Hamilton, ON, Canada
Scleroderma Society of Ontario, Hamilton, ON, Canada
Scleroderma Canada, Hamilton, Canada
Scleroderma Society of Ontario, Hamilton, Canada
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Jewish General Hospital · Lady Davis Institute for Medical Research
Affiliation as printed
Lady Davis Institute for Medical Research of the Jewish General Hospital, 3755 Cote Ste Catherine Road, Montreal, QC, H3T 1E2, Canada
Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada
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Jewish General Hospital · Lady Davis Institute for Medical Research
Affiliation as printed
Lady Davis Institute for Medical Research of the Jewish General Hospital, 3755 Cote Ste Catherine Road, Montreal, QC, H3T 1E2, Canada
Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada
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Jewish General Hospital · Lady Davis Institute for Medical Research
Affiliation as printed
Lady Davis Institute for Medical Research of the Jewish General Hospital, 3755 Cote Ste Catherine Road, Montreal, QC, H3T 1E2, Canada
Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada
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Jewish General Hospital · Lady Davis Institute for Medical Research
Affiliation as printed
Lady Davis Institute for Medical Research of the Jewish General Hospital, 3755 Cote Ste Catherine Road, Montreal, QC, H3T 1E2, Canada
Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada
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Jewish General Hospital · Lady Davis Institute for Medical Research
Affiliation as printed
Lady Davis Institute for Medical Research of the Jewish General Hospital, 3755 Cote Ste Catherine Road, Montreal, QC, H3T 1E2, Canada
Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada
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Jewish General Hospital · Lady Davis Institute for Medical Research
Affiliation as printed
Lady Davis Institute for Medical Research of the Jewish General Hospital, 3755 Cote Ste Catherine Road, Montreal, QC, H3T 1E2, Canada
Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada
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Affiliation as printed
Sint Maartenskliniek, Nijmegen, The Netherlands
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Jewish General Hospital · Lady Davis Institute for Medical Research · McGill University
Affiliation as printed
Department of Medicine, McGill University, Montreal, QC, Canada
Lady Davis Institute for Medical Research of the Jewish General Hospital, 3755 Cote Ste Catherine Road, Montreal, QC, H3T 1E2, Canada
Department of Medicine, McGill University, Montreal, Canada
Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada
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Affiliation as printed
Faculty of Behavioural and Movement Sciences, Vrije Universiteit, Amsterdam, The Netherlands
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Université Paris Cité · Assistance Publique – Hôpitaux de Paris · Université Paris Descartes
Affiliation as printed
Assistance Publique - Hôpitaux de Paris, Paris, France
Université Paris Descartes, Université de Paris, Paris, France
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Université Paris Cité · Assistance Publique – Hôpitaux de Paris · Université Paris Descartes
Affiliation as printed
Assistance Publique - Hôpitaux de Paris, Paris, France
Université Paris Descartes, Université de Paris, Paris, France
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Université Paris Cité · Assistance Publique – Hôpitaux de Paris · Université Paris Descartes
Affiliation as printed
Assistance Publique - Hôpitaux de Paris, Paris, France
Université Paris Descartes, Université de Paris, Paris, France
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Brett D. Thombs corresponding
Jewish General Hospital · Lady Davis Institute for Medical Research · McGill University
Affiliation as printed
Biomedical Ethics Unit, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca
Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca
Department of Medicine, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca
Department of Psychiatry, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca
Department of Psychology, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca
Lady Davis Institute for Medical Research of the Jewish General Hospital, 3755 Cote Ste Catherine Road, Montreal, QC, H3T 1E2, Canada. brett.thombs@mcgill.ca
Biomedical Ethics Unit, McGill University, Montreal, Canada
Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Canada
Department of Medicine, McGill University, Montreal, Canada
Department of Psychiatry, McGill University, Montreal, Canada
Department of Psychology, McGill University, Montreal, Canada
Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada
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Université Paris Cité · Hôpital Cochin · Assistance Publique – Hôpitaux de Paris · Université Paris Descartes
Affiliation as printed
Assistance Publique - Hôpitaux de Paris, Paris, France
Service de Médecine Interne, Centre de Référence Maladies Autoimmunes Systémiques Rares d'Ile de France, Hôpital Cochin, Paris, France
Université Paris Descartes, Université de Paris, Paris, France
Service de Médecine Interne, Centre de Référence Maladies Autoimmunes Systémiques Rares d’Ile de France, Hôpital Cochin, Paris, France
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Affiliation as printed
Ottawa Scleroderma Support Group , Ottawa , Ontario , Canada ; Karen Gottesman ,
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Affiliation as printed
National Scleroderma Foundation , Los Angeles , California , USA;
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Affiliation as printed
Johns Hopkins University School of Medicine , Baltimore , Maryland , USA;
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Affiliation as printed
Amanda Lawrie-Jones , Scleroderma Australia and Scleroderma Victoria , Melbourne , Victoria , Australia;
University of Texas McGovern School of Medicine , Houston , Texas , USA;
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Affiliation as printed
San Diego State University , San Diego , California , USA;
University of Texas McGovern School of Medicine , Houston , Texas , USA;
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Affiliation as printed
McGill University , Montreal , Quebec , Canada;
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Affiliation as printed
Scleroderma Atlantic , Halifax , Nova Scotia , Canada;
St. Joseph's Health Care , London , Ontario , Canada;
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Jewish General Hospital · Lady Davis Institute for Medical Research
Affiliation as printed
University of Texas McGovern School of Medicine , Houston , Texas , USA;
Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada
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Jewish General Hospital · Lady Davis Institute for Medical Research
Affiliation as printed
Toronto Scleroderma Program ,
Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada
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Affiliation as printed
McGill University , Montreal , Quebec , Canada ; Ghassan El-Baalbaki ,
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Vanderbilt University Medical Center
Affiliation as printed
Vanderbilt University Medical Center , Nashville , Tennessee , USA; Amy Gietzen ,
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Affiliation as printed
National Scleroderma Foundation , Tri- State Chapter , Binghamton , New York , USA;
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Affiliation as printed
New York University , New York , New York , USA;
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Yale University · New York University
Affiliation as printed
New York University , New York , New York , USA;
Yale School of Medicine , New Haven , Connecticut , USA;
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Mount Sinai Hospital · University of Toronto · Toronto Western Hospital
Affiliation as printed
Mount Sinai Hospital , Toronto Western Hospital , and University of Toronto , Toronto , Ontario , Canada;
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Jewish General Hospital · Lady Davis Institute for Medical Research
Affiliation as printed
Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada
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Affiliation as printed
Centre Hospitalier Universitaire Dijon Bourgogne , Dijon , France ; Lyne Bissonnette ,
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Affiliation as printed
Hôpital Cochin , Paris , France ; Benjamin Chaigne ,
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Jewish General Hospital · Lady Davis Institute for Medical Research · McGill University
Affiliation as printed
Department of Medicine, McGill University, Montreal, Canada
Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada
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Université Paris Cité · Assistance Publique – Hôpitaux de Paris · Université Paris Descartes
Affiliation as printed
Assistance Publique - Hôpitaux de Paris, Paris, France
Université Paris Descartes, Université de Paris, Paris, France
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