Scleroderma Patient-centered Intervention Network (SPIN) Hand Program

NCT03419208 | Completed

• 1 other identifier: 12-123A
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma; Systemic Sclerosis

Keywords

Systemic Sclerosis; Scleroderma; Hand Function; Intervention; Exercise; Telerehabilitation; eHealth; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Difference in Cochin Hand Function Scale (CHFS) scores between patients offered the intervention and those not offered the intervention 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).

  3 months post-randomization

Secondary Outcomes (13)

• Difference in Cochin Hand Function Scale (CHFS) scores between patients offered the intervention and those not offered the intervention 6-months post-randomization

  6 months post-randomization

• Difference in Cochin Hand Function Scale (CHFS) scores between patients offered the intervention and those not offered the intervention 12-months post-randomization

  12 months post-randomization

• Difference in Cochin Hand Function Scale (CHFS) scores between patients offered the intervention and those not offered the intervention 24-months post-randomization

  24 months post-randomization

• 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

  3 months post-randomization

• 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

  6 months post-randomization

Study Arms (2)

SPIN-HAND Program

EXPERIMENTAL

Offered the SPIN-HAND program

Other: SPIN-HAND Program

Treatment as usual

NO INTERVENTION

Not offered SPIN-HAND program, treatment as usual

Interventions

SPIN-HAND Program OTHER

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.

SPIN-HAND Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A 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
• Be fluent in English or French.
• For SPIN-HAND:
• At least mild hand function limitations (Cochin Hand Function Scale (CHFS) ≥ 3)
• 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)

You may not qualify if:

• Participants not able to access or respond to questionnaires via the internet are excluded
• Participants randomized to the intervention group in the SPIN-HAND feasibility study are excluded

Sponsors & Collaborators

• Lady Davis Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• The Arthritis Society, Canada: collaborator

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3S 1Y9, Canada

Location

Related Publications (2)

• Kwakkenbos L, Jewett LR, Baron M, Bartlett SJ, Furst D, Gottesman K, Khanna D, Malcarne VL, Mayes MD, Mouthon L, Poiraudeau S, Sauve M, Nielson WR, Poole JL, Assassi S, Boutron I, Ells C, van den Ende CH, Hudson M, Impens A, Korner A, Leite C, Costa Maia A, Mendelson C, Pope J, Steele RJ, Suarez-Almazor ME, Ahmed S, Coronado-Montoya S, Delisle VC, Gholizadeh S, Jang Y, Levis B, Milette K, Mills SD, Razykov I, Fox RS, Thombs BD. The Scleroderma Patient-centered Intervention Network (SPIN) Cohort: protocol for a cohort multiple randomised controlled trial (cmRCT) design to support trials of psychosocial and rehabilitation interventions in a rare disease context. BMJ Open. 2013 Aug 7;3(8):e003563. doi: 10.1136/bmjopen-2013-003563.

  PMID: 23929922 BACKGROUND

• Kwakkenbos L, Carrier ME, Welling J, Levis B, Levis AW, Sauve M, Turner KA, Tao L, Aguila K, Carboni-Jimenez A, Canedo-Ayala M, Harb S, van den Ende C, Hudson M, van Breda W, Nguyen C, Boutron I, Rannou F, Thombs BD, Mouthon L; SPIN Investigators. Randomized controlled trial of an internet-based self-guided hand exercise program to improve hand function in people with systemic sclerosis: the Scleroderma Patient-centered Intervention Network Hand Exercise Program (SPIN-HAND) trial. Trials. 2022 Dec 12;23(1):994. doi: 10.1186/s13063-022-06923-4.

  PMID: 36510233 DERIVED

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic; Motor Activity

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Behavior

Study Officials

• Luc Mouthon, MD, PhD

  Hôpital Cochin, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Faculty of Medicine, McGill University Senior Investigator, Lady Davis Institute for Medical Research, Jewish General Hospital

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 1, 2018
• Study Start: March 12, 2018
• Primary Completion: February 24, 2020
• Study Completion: May 30, 2020
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)