N/A
N=40
Scleroderma Patient-centered Intervention Network (SPIN) Hand Program Feasibility Study
Scleroderma · Systemic Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT03092024 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Eligibility: Number of Patients in the SPIN Cohort Who Meet the Cut-off Thresholds for Eligibility — 24; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SPIN-HAND program (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lady Davis Institute
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Eligibility: Number of Patients in the SPIN Cohort Who Meet the Cut-off Thresholds for Eligibility |
24; 16 | — |
| PRIMARY Enrolment: Percentage of Patients Who Consent to Participation |
15; 0 | — |
| PRIMARY Participant Grade on Usability of the SPIN-HAND Program Based on Post-trial Patient Interviews |
8.5 | — |
| PRIMARY Intervention Use: Number of Logins to the SPIN-HAND Program and Number of Participants Who Accessed SPIN-HAND Program Online Features |
7; 3; 5; 11; 6; 10 | — |
| PRIMARY Usage Log Data: Completeness of the Automatic Usage Log Data Values Collected |
100 | — |
| PRIMARY Usage Log Data: Linking of Data From the SPIN Cohort and SPIN-HAND Platforms. |
100 | — |
| PRIMARY Count of Participants Who Reported Technological Problems During Post-trial Patient Interviews |
4; 0; 1; 1 | — |
| SECONDARY The Cochin Hand Function Scale (CHFS) |
21.9; 21.1; 22.0; 20.9 | — |
| SECONDARY EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level |
7; 5; 8; 6; 8; 3 | — |
| SECONDARY EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Visual Analogue Scale (VAS) Scores for Patient Self-rated Health |
64.9; 56.8; 66.9; 54.9 | — |
| SECONDARY Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0 |
40.7; 39.4; 42.2; 41.1; 53.8; 56.7 | — |
Summary
The Scleroderma Patient-centered Intervention Network (SPIN) is an organization established by researchers, health care providers, and people living with scleroderma from Canada, the USA, and Europe. The objectives of SPIN are (1) to assemble a large cohort of scleroderma patients to complete outcome assessments regularly in order to learn more about important problems faced by people living with scleroderma and (2) to develop and test a series of internet-based interventions to help patients manage aspects of scleroderma, including hand limitations.
In the SPIN-HAND feasibility trial, SPIN Cohort participants with at least mild hand function limitations and an indicated interest in using an online hand exercise program will be randomized to be offered the SPIN hand exercise program or to usual care only. The core SPIN hand exercise program consists of 4 modules that address specific aspects of hand function, including Thumb Flexibility and Strength; Finger Bending; Finger Extension; and Wrist Flexibility and Strength. The program also integrates tools to support key components of successful self-management programs, including goal-setting.
The aim of the SPIN-HAND feasibility study is to collect data to assess the feasibility of the steps that need to take place as part of the main trial; required resources; and scientific aspects (e.g., withdrawal rate, outcomes measures). Data will be used to determine whether it is feasible to carry out the main study or whether changes need to be made before conducting a full-scale RCT of the SPIN-HAND program.
Eligibility Criteria
Inclusion Criteria
- SPIN Cohort patients must have a systemic sclerosis (SSc) diagnosis based on 2013 American College of Rheumatology/European League Against Rheumatism criteria confirmed by a SPIN physician, be ≥18 years old, be able to give informed consent, and be fluent in English or French.
- For the feasibility trial, eligible patients will be able to use the online intervention in English, have at least mild hand function limitations (Cochin Hand Function Scale ≥ 3) and have indicated high interest in using an online hand exercise intervention (≥7 on 0-10 scale).
Exclusion Criteria
- Patients not able to access or respond to questionnaires via the internet are excluded.
Data sourced from ClinicalTrials.gov (NCT03092024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.