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

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ClinicalTrials.gov Identifier: NCT03419208
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : March 14, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
The Arthritis Society, Canada
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 (systemic sclerosis or SSc) from Canada, the USA, and Europe. The objectives of SPIN are (1) to assemble a large cohort of SSc patients to complete outcome assessments regularly in order to learn more about important problems faced by people living with SSc and (2) to develop and test a series of internet-based interventions to help patients manage aspects of their disease, including hand limitations.

In SSc, approximately 90% of patients experience significant hand function limitations, which impact overall disability more than any other aspect of the disease. The SPIN hand exercise program was designed by SPIN experts in rehabilitation, behavioural therapies, and e-health interventions, as well as patient representatives in SPIN. The program core consists of 4 modules that address specific aspects of hand function, and integrates tools to support key components of successful self-management programs, including goal-setting and feedback, social modeling, and mastery experiences.

The SPIN-HAND trial is a pragmatic randomized control trial (RCT) embedded in the SPIN Cohort that will evaluate the effect of SPIN's online hand exercise program, in addition to usual care, on hand function and health related quality of life (HRQL) in SSc patients with at least mild hand function limitations. SPIN will randomize 586 SPIN Cohort participants 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.


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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 586 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial of the Scleroderma Patient-centered Intervention Network Hand Exercise Program
Actual Study Start Date : March 12, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : March 1, 2020


Arm Intervention/treatment
Experimental: SPIN-HAND Program
Offered the 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: Treatment as usual
Not offered SPIN-HAND program, treatment as usual



Primary Outcome Measures :
  1. Difference in Cochin Hand Function Scale (CHFS) scores between patients offered the intervention and those not offered the intervention 3-months post-randomization [ Time Frame: 3 months post-randomization ]
    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).


Secondary Outcome Measures :
  1. Difference in Cochin Hand Function Scale (CHFS) scores between patients offered the intervention and those not offered the intervention 6-months post-randomization [ Time Frame: 6 months post-randomization ]
  2. Difference in Cochin Hand Function Scale (CHFS) scores between patients offered the intervention and those not offered the intervention 12-months post-randomization [ Time Frame: 12 months post-randomization ]
  3. Difference in Cochin Hand Function Scale (CHFS) scores between patients offered the intervention and those not offered the intervention 24-months post-randomization [ Time Frame: 24 months post-randomization ]
  4. Difference in Patient Reported Outcomes Measurement Information System (PROMIS-29) profile version 2.0 scores between patients offered the intervention and those not offered the intervention 3-months post-randomization [ Time Frame: 3 months post-randomization ]
    The PROMIS-29 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.

  5. Difference in Patient Reported Outcomes Measurement Information System (PROMIS-29) profile version 2.0 scores between patients offered the intervention and those not offered the intervention 6-months post-randomization [ Time Frame: 6 months post-randomization ]
  6. Difference in Patient Reported Outcomes Measurement Information System (PROMIS-29) profile version 2.0 scores between patients offered the intervention and those not offered the intervention 12-months post-randomization [ Time Frame: 12 months post-randomization ]
  7. Difference in Patient Reported Outcomes Measurement Information System (PROMIS-29) profile version 2.0 scores between patients offered the intervention and those not offered the intervention 24-months post-randomization [ Time Frame: 24 months post-randomization ]
  8. Difference in European Quality of Life-5 Dimensions (EQ-5D) scores between patients offered the intervention and those not offered the intervention 3-months post-randomization [ Time Frame: 3 months post-randomization ]
    The EQ-5D is a 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 HRQL

  9. Difference in European Quality of Life-5 Dimensions (EQ-5D) scores between patients offered the intervention and those not offered the intervention 6-months post-randomization [ Time Frame: 6 months post-randomization ]
  10. Difference in European Quality of Life-5 Dimensions (EQ-5D) scores between patients offered the intervention and those not offered the intervention 12-months post-randomization [ Time Frame: 12 months post-randomization ]
  11. Difference in European Quality of Life-5 Dimensions (EQ-5D) scores between patients offered the intervention and those not offered the intervention 24-months post-randomization [ Time Frame: 24 months post-randomization ]
  12. Usage log data [ Time Frame: Through study completion, 24 months post-randomization ]
    Device (desktop, tablet, mobile), total time spent on intervention and modules, number of logins, number of times multimedia components are accessed, goal sharing, and use of worksheets

  13. Participant reported satisfaction with the SPIN-HAND exercise program [ Time Frame: 3 months post-randomization ]
    The Client Satisfaction Questionnaire (CSQ-8) is an 8 item questionnaire evaluating user satisfaction. Items are scored on a 4-point Likert scale. Total scores range from 8 to 32, with higher scores indicating higher satisfaction with the service. Items have been modified slightly to refer to the SPIN-HAND program, as opposed to a generic service.



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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 inclusion criteria:

    1. A SSc diagnosis based on 2013 American College of Rheumatology/European League Against Rheumatism criteria confirmed by a SPIN physician
    2. Be ≥18 years old, be able to give informed consent
    3. Be fluent in English or French.
  • For SPIN-HAND:

    1. At least mild hand function limitations (Cochin Hand Function Scale (CHFS) ≥ 3)
    2. Have indicated high interest in using an online hand exercise intervention (≥6 on 0-10 scale) and indicated willingness to participate in a trial of the SPIN-HAND program (yes/no)

Exclusion Criteria:

  1. Participants not able to access or respond to questionnaires via the internet are excluded
  2. Participants randomized to the intervention group in the SPIN-HAND feasibility study 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): NCT03419208


Contacts
Contact: Brett Thombs, PhD 514-340-8222 ext 25112 brett.thombs@mcgill.ca
Contact: Linda Kwakkenbos, PhD +31 24 361 1164 l.kwakkenbos@psych.ru.nl

Locations
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3S 1Y9
Contact: Brett Thombs, PhD    5143408222 ext 25112    brett.thombs@mcgill.ca   
Sponsors and Collaborators
Lady Davis Institute
Canadian Institutes of Health Research (CIHR)
The Arthritis Society, Canada
Investigators
Principal Investigator: Luc Mouthon, MD, PhD Hôpital Cochin, Paris, France

Publications:
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: NCT03419208     History of Changes
Other Study ID Numbers: 12-123A
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
URL: http://

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 Function
Intervention
Exercise
Telerehabilitation
eHealth
Physical Therapy

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