TY - JOUR
T1 - Randomized controlled trial of an internet-based self-guided hand exercise program to improve hand function in people with systemic sclerosis
T2 - the Scleroderma Patient-centered Intervention Network Hand Exercise Program (SPIN-HAND) trial
AU - on behalf of the SPIN Investigators
AU - Kwakkenbos, Linda
AU - Carrier, Marie Eve
AU - Welling, Joep
AU - Levis, Brooke
AU - Levis, Alexander W.
AU - Sauve, Maureen
AU - Turner, Kimberly A.
AU - Tao, Lydia
AU - Aguila, Kylene
AU - Carboni-Jiménez, Andrea
AU - Cañedo-Ayala, Mara
AU - Harb, Sami
AU - van den Ende, Cornelia
AU - Hudson, Marie
AU - van Breda, Ward
AU - Nguyen, Christelle
AU - Boutron, Isabelle
AU - Rannou, François
AU - Thombs, Brett D.
AU - Mouthon, Luc
AU - Henry, Richard S.
AU - Bartlett, Susan J.
AU - Fortuné, Catherine
AU - Gottesman, Karen
AU - Guillot, Geneviève
AU - Hummers, Laura K.
AU - Lawrie-Jones, Amanda
AU - Malcarne, Vanessa L.
AU - Mayes, Maureen D.
AU - Nielson, Warren R.
AU - Richard, Michelle
AU - Assassi, Shervin
AU - Benedetti, Andrea
AU - El-Baalbaki, Ghassan
AU - Ells, Carolyn
AU - Fligelstone, Kim
AU - Frech, Tracy
AU - Gietzen, Amy
AU - Harel, Daphna
AU - Hinchcliff, Monique
AU - Johnson, Sindhu R.
AU - Larche, Maggie
AU - Leite, Catarina
AU - Nielsen, Karen
AU - Pope, Janet
AU - Sofia, Tatiana
AU - Schouffoer, Anne A.
AU - Suarez-Almazor, Maria E.
AU - Agard, Christian
AU - Abdallah, Nassim Ait
N1 - Funding Information:
The SPIN team is dedicating the SPIN-HAND program to the memory of Dr. Serge Poiraudeau, who led the SPIN-HAND project team, along with Dr. Luc Mouthon. Dr. Poiraudeau cared deeply for the quality of life and well-being of people living with scleroderma, and without his leadership and dedication, the SPIN-HAND Program would not have been possible. The SPIN Investigators: Richard S. Henry, Jewish General Hospital, Montreal, Quebec, Canada; Susan J. Bartlett, McGill University, Montreal, Quebec, Canada; Catherine Fortuné, Ottawa Scleroderma Support Group, Ottawa, Ontario, Canada; Karen Gottesman, National Scleroderma Foundation, Los Angeles, California, USA; Geneviève Guillot, Sclérodermie Québec, Longueuil, Quebec, Canada; Laura K. Hummers, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; Amanda Lawrie-Jones, Scleroderma Australia and Scleroderma Victoria, Melbourne, Victoria, Australia.
Funding Information:
The SPIN-HAND trial was funded by the Arthritis Society (#SOG-16–380) and the Canadian Institutes of Health Research (PJT-149073). The Scleroderma Patient-centered Intervention Network (SPIN) has received funding for its core activities, including the SPIN Cohort, from the Canadian Institutes of Health Research, the Arthritis Society, the Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Canada, the Jewish General Hospital Foundation, Montreal, Canada, McGill University, Montreal, Canada, the Scleroderma Society of Ontario, Scleroderma Canada, Sclérodermie Québec, Scleroderma Manitoba, Scleroderma Atlantic, the Scleroderma Association of BC, Scleroderma SASK, Scleroderma Australia, Scleroderma New South Wales, Scleroderma Victoria, and Scleroderma Queensland. Dr. Thombs was supported by a Tier 1 Canada Research Chair. Dr. Levis was supported by a Fonds de recherche du Québec – Santé (FRQ-S) Postdoctoral Training Fellowship.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - 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.
AB - 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.
KW - Cohort multiple RCT
KW - Occupational therapy
KW - Physical therapy
KW - Randomized controlled trial
KW - Scleroderma, Systemic
KW - Systemic sclerosis
KW - Tele-rehabilitation
UR - http://www.scopus.com/inward/record.url?scp=85143893425&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85143893425&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06923-4
DO - 10.1186/s13063-022-06923-4
M3 - Article
C2 - 36510233
AN - SCOPUS:85143893425
VL - 23
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
M1 - 994
ER -