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

NCT03092024 | Completed Results

• 1 other identifier: CODIM-MBM-12-123B
• Study Type: interventional
• Target: 40
• 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 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.

Conditions

Scleroderma; Systemic Sclerosis

Keywords

Systemic Sclerosis; Scleroderma; Hand; Intervention; Exercise

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• The Cochin Hand Function Scale (CHFS)

  Baseline, 3 months

• EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level

  Baseline, 3 months

• EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Visual Analogue Scale (VAS) Scores for Patient Self-rated Health

  Baseline, 3 months

• Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0

  Baseline, 3 months

Study Arms (2)

SPIN-HAND program

EXPERIMENTAL

Other: SPIN-HAND program

Not Offered the SPIN-HAND program

NO INTERVENTION

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:

• 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).

You may not qualify if:

• Patients not able to access or respond to questionnaires via the internet are excluded.

Sponsors & Collaborators

• Lady Davis Institute: lead
• Hôpital Cochin: collaborator

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (2)

• Kwakkenbos L, Carrier ME, Welling J, Turner KA, Cumin J, Pepin M, van den Ende C, Schouffoer AA, Hudson M, van Breda W, Sauve M, Mayes MD, Malcarne VL, Nielson WR, Nguyen C, Boutron I, Rannou F, Thombs BD, Mouthon L; SPIN Investigators. Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND). PeerJ. 2022 Aug 4;10:e13471. doi: 10.7717/peerj.13471. eCollection 2022.

  PMID: 35945943 DERIVED

• 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.

  PMID: 35382119 DERIVED

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic; Motor Activity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Brett Thombs
• Organization: Lady Davis Institute

brett.thombs@mcgill.ca

514-340-8222

Study Officials

• Luc Mouthon, MD, PhD

  Hôpital Cochin, Paris, France

  PRINCIPAL INVESTIGATOR

• Serge Poiraudeau, MD, PhD

  Hôpital Cochin, Paris, France

  PRINCIPAL INVESTIGATOR

• Brett Thombs, PhD

  Lady Davis Institute, Montreal, Quebec, Canada

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: March 2, 2017
• First Posted: March 27, 2017
• Study Start: June 1, 2017
• Primary Completion: October 17, 2017
• Study Completion: October 17, 2017
• Last Updated: July 28, 2021
• Results First Posted: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)