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

Study Overview
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Brief Summary
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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.

Detailed Description
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The SPIN Cohort currently currently includes over 1700 patients from 36 sites in Canada, the USA, France, and the United Kingdom. It is anticipated that the Cohort will grow to approximately 2,000 patient by the end of 2017. SPIN Cohort patients complete outcome measures via the internet upon enrolment and subsequently every 3 months. SPIN utilizes the cohort multiple RCT (cmRCT) design as a framework for conducting trials of interventions. SPIN Cohort patients consent to allow personal data to be used for observational research, to assess intervention trial eligibility and, if eligible, be randomized. Patients also consent that if eligible and randomized to usual care, the patient's data can be used to evaluate intervention effectiveness without the patient being notified that the patient has been randomized to the usual care group and not offered the intervention. Thus, in SPIN trials, trial status is masked for patients in the control arm, who are not aware that they are in the trial, but not patients in the intervention arm. The investigative team does not interact with patients for care provision or outcome assessment, which are done automatically via the internet. The SPIN-HAND feasibility study is embedded in the SPIN Cohort and will evaluate the feasibility of conducting full-scale RCT on the SPIN-HAND exercise program. Investigators will randomize 36-40 SPIN Cohort patients with at least mild hand function limitations and an indicated interest in using an online hand exercise program to be offered the hand exercise program or usual care only. Randomization will occur at the time of patients' regular SPIN Cohort assessments. Eligible patients, based on questionnaire responses, will be randomized automatically using simple 1:1 randomization, using a feature in the SPIN Cohort platform, which provides immediate randomization and complete allocation sequence concealment. Feasibility outcomes include patient eligibility and recruitment and numbers and percentages of patients who do not respond to follow-up measures. Use of the internet intervention will be described by presenting the frequency of logins and time spent on the SPIN-HAND program. Analysis of outcome measures will include the completeness of data and presence of floor or ceiling effects. Descriptive statistics will be used to provide means and standard deviations for the measures. Qualitative information and information related to management and usability of the SPIN-HAND program will inform any necessary changes to the intervention or trial procedures.

Official Title
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Feasibility Trial of an Internet-based Exercise Program to Improve Hand Function in Patients With Scleroderma: A Scleroderma Patient-centered Intervention Network (SPIN) Study

Conditions
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Scleroderma, Systemic Sclerosis

Intervention / Treatment
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* Other: SPIN-HAND program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPIN-HAND program<br> | Other: SPIN-HAND program<br>* The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.<br>|
| No Intervention: Not Offered the SPIN-HAND program<br>Treatment as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eligibility: Number of Patients in the SPIN Cohort Who Meet the Cut-off Thresholds for Eligibility | Measure: count of eligible patients | baseline | 
| Enrolment: Percentage of Patients Who Consent to Participation | Measure: count of consenting patients Participants randomized to be offered the intervention received an automated email invitation including a link to the SPIN-HAND Program site and the consent form for the intervention. Participants who were randomized to care as usual were not notified that they had not been offered the intervention and completed their regular SPIN Cohort assessments. Thus, participants who were offered the intervention were not blind to their status, whereas participants assigned to usual care were blind to their participation in the trial and to their assignment to usual care. | Baseline | 
| Participant Grade on Usability of the SPIN-HAND Program Based on Post-trial Patient Interviews | At 3-months post-randomization, qualitative semi-structured interviews were conducted with participants in the intervention arm to assess user acceptability and satisfaction. The interview, consisting of 29 questions, was guided by items of the Patient Education Materials Assessment Tool for Audiovisual Materials and addressed topics related to usability, understandability, organization, and clarity. During these interviews, participants were asked to give the SPIN-HAND program a grade ranging from 0-10, 0 being the worst and 10 being the best possible score. In this table, we report the overall mean grade reported by the intervention arm participants who agreed to be interviewed post-trial. | 3 months | 
| Intervention Use: Number of Logins to the SPIN-HAND Program and Number of Participants Who Accessed SPIN-HAND Program Online Features | Usage of the online SPIN-HAND program was measured based on usage log data, notably the number of participants who logged into the program once, twice or more than two times. Program usage was also measured based on the number of participants who accessed different parts of the online SPIN-HAND program including: the introduction videos, the website tour, the page explaining the level of hand involvement to identify the exercises most relevant to them, the four available modules of the online SPIN-HAND program, as well as the goal-setting feature. | 3 months | 
| Usage Log Data: Completeness of the Automatic Usage Log Data Values Collected | Here we report our success in collecting participant usage log data. This is reported as the percentage of the usage log data that was successfully collected. | 3 months | 
| Usage Log Data: Linking of Data From the SPIN Cohort and SPIN-HAND Platforms. | We report our percentage success in linking data coming from the SPIN Cohort and SPIN-HAND platforms. | 3 months | 
| Count of Participants Who Reported Technological Problems During Post-trial Patient Interviews | Measure: count of technological problems reported SPIN personnel reported no issues with the technological performance of the online SPIN-HAND program. As part of the user feedback interviews, participants of the SPIN-HAND program were asked whether they experienced technological difficulties during the intervention. Here, we report the number of intervention-arm participants who reported technological issues, during these post-trial interviews. In cases of technological difficulty experienced by participants, technological assistance was provided by the SPIN team, and the issues were resolved. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Cochin Hand Function Scale (CHFS) | The Cochin Hand Function Scale (CHFS) measures functional ability of the hand among patients with rheumatic diseases. The 18-item CHFS measures ability to perform daily hand-related activities (e.g., kitchen, dressing oneself, hygiene, writing/typing). Items are scored on a 0-5 Likert scale (0=without difficulty; 5=impossible). Higher scores indicate less functionality. The total score is obtained by adding the scores of all items (range 0-90). | Baseline, 3 months | 
| EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level | The EuroQol Group 5 Dimension 5 Level (EQ-5D-5L) is standardized questionnaire measuring 5 dimensions related to health related quality of life, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, items are rated from 1 (no problems) to 5 (extreme problems). Here we report the number of intervention arm and control arm participants who gave scores ranging 1-5 for the different dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), at baseline and at 3-months post randomization. | Baseline, 3 months | 
| EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Visual Analogue Scale (VAS) Scores for Patient Self-rated Health | As part of the EQ-5D-5L questionnaire, a Visual Analogue Scale (VAS) records the patient's self-rated health on a scale from 0-100 where the endpoints are labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0). Here we report the mean (and standard deviations) self-reported patient health VAS scores of intervention arm participants and control arm participants (i.e. usual care), at baseline and at 3-months post-randomization. | Baseline, 3 months | 
| Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0 | Measures 8 domains of health status with 4 items for each of 7 domains (physical function, anxiety, depression, fatigue, sleep disturbance, social roles and activities, pain interference) plus a single item for pain intensity. Items are scored on a 5-point scale (range 1-5), with different response options for different domains, and the single pain intensity item is measured on an 11-point rating scale. Higher scores represent more of the domain being measured; that is, better physical function and ability to participate in social roles and activities, but higher levels of anxiety, depression, fatigue, sleep disturbance, pain interference, and pain intensity. Total raw scores are obtained by summing item scores for each domain, which are converted into T-scores standardized from the general US population (mean=50, SD=10). Here, we report the pre- and post-intervention total scores for PROMIS-29 domains. | Baseline, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervention, Systemic Sclerosis, Scleroderma, Hand, Exercise