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

Research

Linda Kwakkenbos¹  Alexander W. Levis²  Ward van Breda³  Andrea Carboni-Jiménez⁴  Kimberly A. Turner⁴  Lydia Tao⁴  Sami Harb⁴  Mara Cañedo-Ayala⁴  Kylene Aguila⁴  Marie-Eve Carrier⁴  Brooke Levis⁵  Marie Hudson⁶  Brett D. Thombs⁷  Joep Welling⁸  Maureen Sauve⁹  Cornelia van den Ende^1,10  Christelle Nguyen^1,11  François Rannou^1,11  Isabelle Boutron^1,11  Luc Mouthon^1,12 

[1] Clinical Psychology, Radboud University, Nijmegen, The Netherlands;Department of Medical Psychology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands;Department of Biostatistics, Harvard T. H. Chan School of Public Health, Cambridge, MA, USA;Faculty of Behavioural and Movement Sciences, Vrije Universiteit, Amsterdam, The Netherlands;Lady Davis Institute for Medical Research of the Jewish General Hospital, 3755 Cote Ste Catherine Road, H3T 1E2, Montreal, QC, Canada;Lady Davis Institute for Medical Research of the Jewish General Hospital, 3755 Cote Ste Catherine Road, H3T 1E2, Montreal, QC, Canada;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, H3T 1E2, Montreal, QC, Canada;Department of Medicine, McGill University, Montreal, QC, Canada;Lady Davis Institute for Medical Research of the Jewish General Hospital, 3755 Cote Ste Catherine Road, H3T 1E2, Montreal, QC, Canada;Department of Medicine, McGill University, Montreal, QC, Canada;Department of Psychiatry, McGill University, Montreal, QC, Canada;Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC, Canada;Department of Psychology, McGill University, Montreal, QC, Canada;Biomedical Ethics Unit, McGill University, Montreal, QC, Canada;NVLE Dutch Patient Organization for Systemic Autoimmune Diseases, Utrecht, The Netherlands;Scleroderma Society of Ontario, Hamilton, ON, Canada;Scleroderma Canada, Hamilton, ON, Canada;Sint Maartenskliniek, Nijmegen, The Netherlands;Université Paris Descartes, Université de Paris, Paris, France;Assistance Publique - Hôpitaux de Paris, Paris, France;Université Paris Descartes, Université de Paris, Paris, France;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;

关键词: Cohort multiple RCT;    Occupational therapy;    Physical therapy;    Randomized controlled trial;    Scleroderma, Systemic;    Systemic sclerosis;    Tele-rehabilitation;   

DOI  :  10.1186/s13063-022-06923-4

 received in 2022-06-20, accepted in 2022-11-12,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundSystemic 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.MethodsThe 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.ResultsIn 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.ConclusionThe 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 registrationNCT03419208. Registered on February 1, 2018.

【 授权许可】

CC BY   
© The Author(s) 2022

【 图 表 】

Fig. 2