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N/A N=40 Randomized Supportive Care

Scleroderma Patient-centered Intervention Network (SPIN) Hand Program Feasibility Study

Scleroderma · Systemic Sclerosis

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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