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
Authors: Kwakkenbos Linda , Carrier Marie-Eve , Welling Joep , Levis Brooke , Levis Alexander W. , Sauve Maureen , Turner Kimberly A. , Tao Lydia , Aguila Kylene , Carboni-Jiménez Andrea , Cañedo-Ayala Mara , Harb Sami , van den Ende Cornelia , Hudson Marie , van Breda Ward , Nguyen Christelle , Boutron Isabelle , Rannou François , Thombs Brett D. , Mouthon Luc ,   on behalf of the SPIN Investigators, Henry Richard S. , Bartlett Susan J. , Fortuné Catherine , Gottesman Karen , Guillot Geneviève , Hummers Laura K. , Lawrie-Jones Amanda , Malcarne Vanessa L. , Mayes Maureen D. , Nielson Warren R. , Richard Michelle , Assassi Shervin , Benedetti Andrea , El-Baalbaki Ghassan , Ells Carolyn , Fligelstone Kim , Frech Tracy , Gietzen Amy , Harel Daphna , Hinchcliff Monique , Johnson Sindhu R. , Larche Maggie , Leite Catarina , Nielsen Karen , Pope Janet , Sofia Tatiana , Schouffoer Anne A. , Suarez-Almazor Maria E. , Agard Christian , Abdallah Nassim Ait , André Marc , Bernstein Elana J. , Berthier Sabine , Bissonnette Lyne , Bruns Alessandra , Carreira Patricia , Casadevall Marion , Chaigne Benjamin , Chung Lorinda , Crichi Benjamin , Denton Christopher , Domsic Robyn , Dunne James V. , Dunogue Bertrand , Fare Regina , Farge-Bancel Dominique , Fortin Paul R. , Gordon Jessica , Granel-Rey Brigitte , Guffroy Aurélien , Gyger Genevieve , Hachulla Eric , Herrick Ariane L. , Hoa Sabrina , Ikic Alena , Jones Niall , Kafaja Suzanne , Khalidi Nader , Lambert Marc , Launay David , Lee Yvonne C. , Maillard Hélène , Maltez Nancy , Manning Joanne , Marie Isabelle , Lopez Maria Martin , Martin Thierry , Masetto Ariel , Maurier François , Mekinian Arsene , Díaz Sheila Melchor , Nikpour Mandana , Olagne Louis , Poindron Vincent , Proudman Susanna , Régent Alexis , Rivière Sébastien , Robinson David , Rodríguez Esther , Roux Sophie , Smets Perrine , Sobanski Vincent , Spiera Robert , Steen Virginia , Sutton Evelyn , Thorne Carter , Varga John , Wilcox Pearce , Discepola Marie-Nicole , Montemurro Laury , Nassar Elsa Lynn , Neyer Marieke Alexandra , Nordlund Julia , Østbø Nora , Provencher Sabrina 
Published: December 2022

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.