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

on behalf of the SPIN Investigators

doi:10.1186/s13063-022-06923-4

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

on behalf of the SPIN Investigators

Medicine, Rheumatology Division

Research output: Contribution to journal › Article › peer-review

3 Scopus citations

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.

Original language	English (US)
Article number	994
Journal	Trials
Volume	23
Issue number	1
DOIs	https://doi.org/10.1186/s13063-022-06923-4
State	Published - Dec 2022

Funding

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 Fortun\u00E9, Ottawa Scleroderma Support Group, Ottawa, Ontario, Canada; Karen Gottesman, National Scleroderma Foundation, Los Angeles, California, USA; Genevi\u00E8ve Guillot, Scl\u00E9rodermie Qu\u00E9bec, 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. The SPIN-HAND trial was funded by the Arthritis Society (#SOG-16\u2013380) 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, Scl\u00E9rodermie Qu\u00E9bec, 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 Qu\u00E9bec \u2013 Sant\u00E9 (FRQ-S) Postdoctoral Training Fellowship.

Keywords

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

ASJC Scopus subject areas

Medicine (miscellaneous)
Pharmacology (medical)

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10.1186/s13063-022-06923-4

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@article{dfa0b81474e54004a07970815a3a2099,

title = "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",

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.",

keywords = "Cohort multiple RCT, Occupational therapy, Physical therapy, Randomized controlled trial, Scleroderma, Systemic, Systemic sclerosis, Tele-rehabilitation",

author = "{on behalf of the SPIN Investigators} and Linda Kwakkenbos and Carrier, {Marie Eve} and Joep Welling and Brooke Levis and Levis, {Alexander W.} and Maureen Sauve and Turner, {Kimberly A.} and Lydia Tao and Kylene Aguila and Andrea Carboni-Jim{\'e}nez and Mara Ca{\~n}edo-Ayala and Sami Harb and {van den Ende}, Cornelia and Marie Hudson and {van Breda}, Ward and Christelle Nguyen and Isabelle Boutron and Fran{\c c}ois Rannou and Thombs, {Brett D.} and Luc Mouthon and Henry, {Richard S.} and Bartlett, {Susan J.} and Catherine Fortun{\'e} and Karen Gottesman and Genevi{\`e}ve Guillot and Hummers, {Laura K.} and Amanda Lawrie-Jones and Malcarne, {Vanessa L.} and Mayes, {Maureen D.} and Nielson, {Warren R.} and Michelle Richard and Shervin Assassi and Andrea Benedetti and Ghassan El-Baalbaki and Carolyn Ells and Kim Fligelstone and Tracy Frech and Amy Gietzen and Daphna Harel and Monique Hinchcliff and Johnson, {Sindhu R.} and Maggie Larche and Catarina Leite and Karen Nielsen and Janet Pope and Tatiana Sofia and Schouffoer, {Anne A.} and Suarez-Almazor, {Maria E.} and Lee, {Yvonne C.} and John Varga",

note = "Publisher Copyright: {\textcopyright} 2022, The Author(s).",

year = "2022",

month = dec,

doi = "10.1186/s13063-022-06923-4",

language = "English (US)",

volume = "23",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

number = "1",

}

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. / on behalf of the SPIN Investigators.
In: Trials, Vol. 23, No. 1, 994, 12.2022.

Research output: Contribution to journal › Article › peer-review

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 - Lee, Yvonne C.

AU - Varga, John

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

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SN - 1745-6215

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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

Abstract

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