SclerodermaSPIN-HAND-FNCT03092024
Scleroderma Patient-centered Intervention Network (SPIN) Hand Program Feasibility Study
A study testing SPIN-HAND program in people with Scleroderma and Systemic Sclerosis, run by Lady Davis Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Systemic Sclerosis
- What is being tested?
- SPIN-HAND program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2017to 17 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Patients not able to access or respond to questionnaires via the internet are excluded.
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Scleroderma, Systemic Sclerosis
- Being tested
- SPIN-HAND program
- Keywords
- Systemic Sclerosis, Scleroderma, Hand, Intervention, Exercise
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPIN-HAND programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SPIN-HAND program | Experimental | Not described Receives: Other: SPIN-HAND program |
| Not Offered the SPIN-HAND program | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility: Number of Patients in the SPIN Cohort Who Meet the Cut-off Thresholds for Eligibility
Measure: count of eligible patients
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (4)
The Cochin Hand Function Scale (CHFS)
The Cochin Hand Function Scale (CHFS) 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. The total score is obtained by adding the scores of all items (range 0-90).
Measured: Baseline, 3 months
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
The EuroQol Group 5 Dimension 5 Level (EQ-5D-5L) is standardized questionnaire measuring 5 dimensions related to health related quality of life, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, items are rated from 1 (no problems) to 5 (extreme problems). Here we report the number of intervention arm and control arm participants who gave scores ranging 1-5 for the different dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), at baseline and at 3-months post randomization.
Measured: Baseline, 3 months
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Visual Analogue Scale (VAS) Scores for Patient Self-rated Health
As part of the EQ-5D-5L questionnaire, a Visual Analogue Scale (VAS) records the patient's self-rated health on a scale from 0-100 where the endpoints are labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0). Here we report the mean (and standard deviations) self-reported patient health VAS scores of intervention arm participants and control arm participants (i.e. usual care), at baseline and at 3-months post-randomization.
Measured: Baseline, 3 months
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
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. Total raw scores are obtained by summing item scores for each domain, which are converted into T-scores standardized from the general US population (mean=50, SD=10). Here, we report the pre- and post-intervention total scores for PROMIS-29 domains.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start1 Jun 2017
- Primary completion17 Oct 2017
- Study completion17 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Cochin
- Responsible party
- Principal investigator, Brett D Thombs, Lady Davis Institute
- Investigators
- Luc Mouthon, MD, PhD, Principal investigator, Hôpital Cochin, Paris, FranceSerge Poiraudeau, MD, PhD, Principal investigator, Hôpital Cochin, Paris, FranceBrett Thombs, PhD, Principal investigator, Lady Davis Institute, Montreal, Quebec, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092024
- Sponsor's protocol ID
- CODIM-MBM-12-123B
- Acronym
- SPIN-HAND-F
- Status last verified
- Jul 2021
- First submitted
- 2 Mar 2017
- Last updated
- 28 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request
Publications
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.
PubMed 35945943Carrier 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.
PubMed 35382119
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03092024
- Acronym / sponsor ID
- SPIN-HAND-F / CODIM-MBM-12-123B
- Conditions
- Scleroderma, Systemic Sclerosis
- Keywords
- Systemic Sclerosis, Scleroderma, Hand, Intervention, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Collaborators
- Hôpital Cochin
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 17 Oct 2017 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Posted 28 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPIN-HAND program | Experimental | Other: SPIN-HAND program |
| Not Offered the SPIN-HAND program | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients not able to access or respond to questionnaires via the internet are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPIN-HAND programThe 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. | Other | SPIN-HAND program |
Primary outcome
Eligibility: Number of Patients in the SPIN Cohort Who Meet the Cut-off Thresholds for Eligibility
Time frame: baseline
Measure: count of eligible patients
Enrolment: Percentage of Patients Who Consent to Participation
Time frame: Baseline
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.
Participant Grade on Usability of the SPIN-HAND Program Based on Post-trial Patient Interviews
Time frame: 3 months
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.
Intervention Use: Number of Logins to the SPIN-HAND Program and Number of Participants Who Accessed SPIN-HAND Program Online Features
Time frame: 3 months
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.
Usage Log Data: Completeness of the Automatic Usage Log Data Values Collected
Time frame: 3 months
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.
Usage Log Data: Linking of Data From the SPIN Cohort and SPIN-HAND Platforms.
Time frame: 3 months
We report our percentage success in linking data coming from the SPIN Cohort and SPIN-HAND platforms.
Count of Participants Who Reported Technological Problems During Post-trial Patient Interviews
Time frame: 3 months
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.
4 secondary outcomes
The Cochin Hand Function Scale (CHFS)
Time frame: Baseline, 3 months
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Number of Participants Per Dimension Per Level
Time frame: Baseline, 3 months
EuroQol Group 5 Dimension 5 Level (EQ-5D-5L): Visual Analogue Scale (VAS) Scores for Patient Self-rated Health
Time frame: Baseline, 3 months
Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35945943Kwakkenbos 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.
- Derived from this study: PubMed 35382119Carrier 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.
- Individual participant dataSharing planned: Yes. Upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc Mouthon, MD, PhD principal investigator
Hôpital Cochin, Paris, France
Serge Poiraudeau, MD, PhD principal investigator
Hôpital Cochin, Paris, France
Brett Thombs, PhD principal investigator
Lady Davis Institute, Montreal, Quebec, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPIN-HAND program in people with Scleroderma and Systemic Sclerosis, run by Lady Davis Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility: Number of Patients in the SPIN Cohort Who Meet the Cut-off Thresholds for Eligibility (time frame: baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03092024, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021; AzTrials last refreshed its copy on 27 Oct 2026.