Clinical trial NCT03092024: Scleroderma Patient-centered Intervention Network (SPIN) Hand Program Feasibility Study
Official title: Feasibility Trial of an Internet-based Exercise Program to Improve Hand Function in Patients With Scleroderma: A Scleroderma Patient-centered Intervention Network (SPIN) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleroderma
Systemic Sclerosis
Keywords: Systemic Sclerosis
Scleroderma
Hand
Intervention
Exercise
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
Collaborators: name: Hôpital Cochin
First posted: 2017-03-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Eligibility: Number of Patients in the SPIN Cohort Who Meet the Cut-off Thresholds for Eligibility
timeFrame: baseline
measure: Enrolment: Percentage of Patients Who Consent to Participation
timeFrame: Baseline
measure: Participant Grade on Usability of the SPIN-HAND Program Based on Post-trial Patient Interviews
timeFrame: 3 months
measure: Intervention Use: Number of Logins to the SPIN-HAND Program and Number of Participants Who Accessed SPIN-HAND Program Online Features
timeFrame: 3 months
measure: Usage Log Data: Completeness of the Automatic Usage Log Data Values Collected
timeFrame: 3 months
measure: Usage Log Data: Linking of Data From the SPIN Cohort and SPIN-HAND Platforms.
timeFrame: 3 months
measure: Count of Participants Who Reported Technological Problems During Post-trial Patient Interviews
timeFrame: 3 months
Secondary outcomes:
measure: The Cochin Hand Function Scale (CHFS)
timeFrame: Baseline, 3 months
measure: EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
timeFrame: Baseline, 3 months
measure: EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Visual Analogue Scale (VAS) Scores for Patient Self-rated Health
timeFrame: Baseline, 3 months
measure: Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Hôpital Cochin, Paris, France
name: Luc Mouthon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Cochin, Paris, France
name: Serge Poiraudeau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lady Davis Institute, Montreal, Quebec, Canada
name: Brett Thombs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carrier ME, Kwakkenbos L, Boutron I, Welling J, Sauve M, van den Ende C, Schouffoer AA, Hudson M, Thombs BD, Mouthon L; SPIN Investigators*. Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND): Study protocol. J Scleroderma Relat Disord. 2018 Feb;3(1):91-97. doi: 10.5301/jsrd.5000263. Epub 2017 Oct 16.