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.

A Systematic Review of the Statistical Methods Adopted for Analyzing Follow-Up Data in Cohort Multiple Randomized Controlled Trial

“…Kwakkenbos [30] conducted a study where for a standardized mean difference of 0.25, 5% level of significance, 80% power, and 10% loss to follow-up, a minimum of 586 participants were required to conduct the study. There was no clarity on whether 586 in each group is required, as reproducing the said sample size resulted in 279 in each group.…”

“…Dupuis [29] and Pielkenrood [31] provided no information regarding blinding. Kwakkenbos [30] blinded the statistical analysts to trial arm allocation, but were again unblinded for the complier effect analyses, which required the knowledge of intervention arm consent. Fahim [32] blinded the investigators who performed the analyses.…”

“…The sample size determination method was also found missing from this article. The other six articles [23,24,26,28,30,32] used the CONSORT reporting guidelines thoroughly.…”

Systemic sclerosis: one year in review 2023

“…Outcome data at 3 and 6 months showed that CHFS did not differ significantly between patients undergoing SPIN-HAND and those who did not receive any online support, nor did the PROs analysed. The scarce success of this kind of intervention could be due to the method of enrolment and to the lack of guidance of a health professional (65).…”