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Randomized Controlled Trial
. 2022 Aug 4:10:e13471.
doi: 10.7717/peerj.13471. eCollection 2022.

Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND)

Linda Kwakkenbos  1 , Marie-Eve Carrier  2 , Joep Welling  3 , Kimberly A Turner  2 , Julie Cumin  2 , Mia Pépin  2 , Cornelia van den Ende  4 , Anne A Schouffoer  5   6 , Marie Hudson  2   7 , Ward van Breda  8 , Maureen Sauve  9   10 , Maureen D Mayes  11 , Vanessa L Malcarne  12 , Warren R Nielson  13 , Christelle Nguyen  14 , Isabelle Boutron  15   16 , François Rannou  14   17 , Brett D Thombs  2   7   18   19   20   21 , Luc Mouthon  22   23 ; SPIN Investigators
Affiliations
Randomized Controlled Trial

Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND)

Linda Kwakkenbos et al. PeerJ. .

Abstract

Purpose: The Scleroderma Patient-centered Intervention Network (SPIN) online hand exercise program (SPIN-HAND), is an online self-help program of hand exercises designed to improve hand function for people with scleroderma. The objective of this feasibility trial was to evaluate aspects of feasibility for conducting a full-scale randomized controlled trial of the SPIN-HAND program.

Materials and methods: The feasibility trial was embedded in the SPIN cohort and utilized the cohort multiple randomized controlled trial (cmRCT) design. In the cmRCT design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about trials conducted using the cohort. When trials were conducted in the cohort, participants randomized to the intervention were informed and consented to access the intervention. Participants randomized to control were not informed that they have not received an intervention. All participants eligible and randomized to participate in the trial were included in analyses on an intent-to-treat basis. Cohort participants with a Cochin Hand Function Scale score ≥ 3/90 and an interest in using an online hand-exercise intervention were randomized (1:1 ratio) to be offered as usual care plus the SPIN-HAND Program or usual care for 3 months. User satisfaction was assessed with semi-structured interviews.

Results: Of the 40 randomized participants, 24 were allocated to SPIN-HAND and 16 to usual care. Of 24 participants randomized to be offered SPIN-HAND, 15 (63%) consented to use the program. Usage of SPIN-HAND content among the 15 participants who consented to use the program was low; only five (33%) logged in more than twice. Participants found the content relevant and easy to understand (satisfaction rating 8.5/10, N = 6). Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly. The required technical support was minimal.

Conclusions: Trial methodology functioned as designed, and the SPIN-HAND Program was feasibly delivered; however, the acceptance of the offer and use of program content among accepters were low. Adjustments to information provided to potential participants will be implemented in the full-scale SPIN-HAND trial to attempt to increase offer acceptance.

Trial registration: ClinicalTrials.gov NCT03092024.

Keywords: Cohort multiple RCT; Feasibility trial; Internet intervention; Occupational therapy; Physical therapy; Scleroderma; Systemic sclerosis; Tele-rehabilitation.

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Conflict of interest statement

Luc Mouthon reported personal fees from Actelion/Johnson & Johnson, grants from LFB, non-financial support from Octapharma, and non-financial support from Grifols, all outside the submitted work. All other authors declare: no support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous three years. All authors declare no other relationships or activities that could appear to have influenced the submitted work.

Figures

Figure 1
Figure 1. Menu of the SPIN-HAND Program exercise modules.
Figure 2
Figure 2. Goal setting tool.
Figure 3
Figure 3. Patient stories page.
Figure 4
Figure 4. Instructional video of hand exercise and illustration of common mistakes.
Figure 5
Figure 5. Information page providing guidance on selecting intervention intensity levels (mild to moderate and more severe hand involvement).
Figure 6
Figure 6. Pictures illustrating alternate versions on how to perform the exercise for patients with very severe hand involvement.
Figure 7
Figure 7. SPIN Cohort and SPIN-HAND feasibility trial flow.
See this image and copyright information in PMC

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