An interventional study of SPIN-HAND Program in Scleroderma and Systemic Sclerosis, sponsored by Lady Davis Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-05.
Sponsored by Lady Davis Institute · Not applicable, Interventional, and Supportive care
Among 34 studies in Scleroderma, Diffuse with a site in Canada — 5 open to participants now, 8 under way, 2 of them phase 3. Scleroderma, Diffuse · Canada.
Among the 34 studies in Scleroderma, Diffuse with a site in Canada, this one is the 4th largest by enrollment of the 32 interventional ones that give a count, is one of 3 that started in 2018, is one of 11 with no phase, and was the 13th registered.
310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.
Browse Scleroderma, Diffuse studies →5 of the 34 studies in Scleroderma, Diffuse with a site in Canada are open now. Recruiting first, the newest first:
Allogene Therapeutics · Sites in Canada, United States
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Sites in Canada
Primus Pharmaceuticals · Sites in Canada
University of British Columbia · Sites in Canada
The Hospital for Sick Children · Sites in Canada
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 55 Scleroderma, Diffuse studies recruiting now, 28 (51%) set no upper age limit and 20 (36%) stop at 75 or younger; 10 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
34 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 14 · Phase 3 5
First in 2005; this study’s year is marked. 3 started in 2018.
This study's enrollment of 466 is above the median of 38 across 227 interventional studies indexed under Scleroderma, Diffuse.
Median enrollment 82 across the 32 interventional studies, 42 across the 2 observational. Of the 23 that completed or were terminated, 9 (39%) have results posted.
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16 of 34 have an industry lead sponsor. The 10 most frequent:
Lady Davis Institute is the lead sponsor of 46 studies on the registry; 7 are open to participants now.
Lady Davis Institute has 9 studies filed under Scleroderma, Diffuse — fewer than ten, so there is no comparison to draw.
4 of the studies in Scleroderma, Diffuse with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05925803Phase 3AstraZenecaDetermine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) | 2027-01-06 |
| NCT06847750The Hospital for Sick ChildrenElastography Ultrasound in Localized Scleroderma (Morphea) Study | 2026-12-31 |
| NCT03800017University of British ColumbiaSkeletal Muscle Function in Interstitial Lung Disease | 2026-12-31 |
| NCT06256575Primus PharmaceuticalsStudy of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis | 2027-07-15 |
Among the 34 studies in Scleroderma, Diffuse with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
For individuals with SSc, skin and tendon involvement of the hands with significant functional impairment is nearly universal. Hand function limitations impact disability more than any other aspect of the disease. However, given the challenges of conducting high-quality, adequately powered clinical trials and disseminating disease management tools in a rare disease context, proven rehabilitation interventions, including those for hands, are typically not available to rare disease patients. To address this gap, the Scleroderma Patient-centered Intervention Network (SPIN) was founded to (1) assemble a large, multinational cohort of SSc patients as a framework for large-scale rehabilitation and self-management intervention trials; and (2) to develop, test, and disseminate effective disease management tools to patients with SSc.
The SPIN Cohort currently includes over 2000 English- and French-speaking patients from over 40 sites in Canada, the USA, France, and the United Kingdom. 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 their data to be used for observational research, to assess intervention trial eligibility and, if eligible, be randomized. They also consent that if eligible and randomized to usual care, their data can be used to evaluate intervention effectiveness without them being notified that they have 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, but not the intervention arm.
The SPIN-HAND trial will evaluate the effect on hand function and HRQL of offering SPIN's online hand exercise program, in addition to usual care, to Cohort patients who have at least mild hand function limitations. 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, including (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 also integrates tools to support key components of successful self-management programs, including goal-setting and feedback, social modeling, and mastery experiences. 586 SPIN Cohort participants will be enrolled in SPIN-HAND. Eligible patients will be able to use the online intervention in English or French, have at least mild hand function limitations (Cochin Hand Function Scale (CHFS) ≥ 3) and have indicated high interest in using an online hand exercise intervention (≥6 on 0-10 scale).
Randomization will occur at the time of patients' regular SPIN Cohort assessments. Eligible patients, based on questionnaire responses, will be randomized automatically with a 3:2 ratio, using a feature in the SPIN Cohort platform, which provides immediate randomization and complete allocation sequence concealment. A 3:2 ratio is being used in order to increase the number of patients who receive the intervention and to support secondary analyses that examine compliers versus non-compliers.
Trial outcomes will be assessed immediately pre-randomization and at 3 months, 6 months, 12 months, and 24 months post-randomization via the SPIN Cohort for both patients randomized to be offered the intervention and patients who receive usual care only. The primary outcome analysis will compare CHFS scores between eligible patients offered the intervention and those not offered the intervention at 3 months post-randomization. Secondary outcomes will include patient-reported health status, usage logs, user satisfaction, and HRQL.
Statistical analyses will be done blind to trial arm allocation. For the primary analysis, an intent-to-treat approach that compares all patients randomized to be offered versus not offered the intervention will be used. Intervention effects will be estimated using a generalized linear model, adjusted for baseline CHFS scores, recruitment centre, sex, age, disease duration, and diffuse versus limited SSc status. Missing data effects will be investigated using multiple imputation.
Analysis of secondary outcome variables and time points will be done similarly. In addition, complier-average causal effect analysis will be used to estimate effects among patients who accept the intervention offer compared to similar patients in the usual care group. Analysis of usage log data will be conducted to understand the association of uptake and use patterns with intervention effect.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
SPIN Cohort inclusion criteria:
For SPIN-HAND:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Offered the SPIN-HAND program
Other: SPIN-HAND Program
Not offered SPIN-HAND program, treatment as usual
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.
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).
Time frame: 3 months post-randomization
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
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
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
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
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.
Time frame: 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
Time frame: 6 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 12-months post-randomization
Time frame: 12 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 24-months post-randomization
Time frame: 24 months post-randomization
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
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
Time frame: 3 months post-randomization
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
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
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
Usage log data
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
Time frame: Through study completion, 24 months post-randomization
Participant reported satisfaction with the SPIN-HAND exercise program
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.
Time frame: 3 months post-randomization
Plan to share: Yes
Ran from Mar 2018 to primary completion in Feb 2020, 23 months.
Of 51 non-industry interventional studies with no phase under Scleroderma, Diffuse, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's 23 months is above that.
Counting every sponsor, half of 53 studies reached it within 16 months; a quarter within 4 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Lady Davis Institute