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

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ClinicalTrials.gov Identifier: NCT03092024
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : December 26, 2017
Sponsor:
Collaborator:
Hôpital Cochin
Information provided by (Responsible Party):
Brett Thombs, Lady Davis Institute

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.


Condition or disease Intervention/treatment Phase
Scleroderma Systemic Sclerosis Other: SPIN-HAND program Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : October 17, 2017
Actual Study Completion Date : October 17, 2017


Arm Intervention/treatment
Experimental: SPIN-HAND program Other: SPIN-HAND program
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.

No Intervention: Not Offered the SPIN-HAND program
Treatment as usual



Primary Outcome Measures :
  1. Eligibility: Number of patients in the SPIN Cohort who meet the cut-off thresholds for eligibility [ Time Frame: baseline ]
    Measure: count of eligible patients

  2. Enrolment: Percentage of patients who consent to participation [ Time Frame: Baseline ]
    Measure: count of consenting patients

  3. Participant feedback on usability [ Time Frame: 3 months ]
    Patient interviews

  4. Intervention use: Number of logins and time spent on the SPIN-HAND program [ Time Frame: 3 months ]
    Measure: usage log data

  5. Usage log data: Completeness of the automatic usage log data values collected [ Time Frame: 3 months ]
    Measure: usage log data

  6. Usage log data: Linking of data from the SPIN Cohort and SPIN-HAND platforms. [ Time Frame: 3 months ]
    Measure: Usage log data

  7. Technological problems [ Time Frame: 3 months ]
    Measure: count of technological problems reported by staff and patients


Secondary Outcome Measures :
  1. The Cochin Hand Function Scale (CHFS) [ Time Frame: Baseline, 3 months ]
    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.

  2. EuroQol Group: EQ-5D-5L [ Time Frame: Baseline, 3 months ]
    5-item standardized questionnaire, measuring 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The items are rated from 1 (no problems) to 3 (extreme problems). Scores range from -0.59 to 1.00 and reflect overall Health Related Quality of Life

  3. Patient Reported Outcomes Measurement Information System (PROMIS-29) profile version 2.0 [ Time Frame: Baseline, 3 months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092024


Locations
Canada, Quebec
Jewish General Hospital
Montréal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Lady Davis Institute
Hôpital Cochin
Investigators
Principal Investigator: Luc Mouthon, MD, PhD Hôpital Cochin, Paris, France
Principal Investigator: Serge Poiraudeau, MD, PhD Hôpital Cochin, Paris, France

Responsible Party: Brett Thombs, Professor, Faculty of Medicine, McGill University Senior Investigator, Lady Davis Institute for Medical Research, Jewish General Hospital, Lady Davis Institute
ClinicalTrials.gov Identifier: NCT03092024     History of Changes
Other Study ID Numbers: CODIM-MBM-12-123B
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon request

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brett Thombs, Lady Davis Institute:
Systemic Sclerosis
Scleroderma
Hand
Intervention
Exercise

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Pathologic Processes
Connective Tissue Diseases
Skin Diseases