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New online program aims to help scleroderma patients take control of their symptoms

NCT ID NCT04246528

Symptom relief Sponsor: Lady Davis Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This trial tests an online self-management program for people with scleroderma (systemic sclerosis). Participants watch videos of patients and health professionals teaching techniques to manage pain, fatigue, skin issues, and more. The program also includes group video calls led by trained peers. The goal is to see if the program boosts patients' confidence in managing their disease compared to usual care alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SPIN-SELF Program (online self-management modules with peer-led videoconference group sessions)
What this could lead to
If successful, this program could help people with scleroderma feel more confident managing their symptoms and improve their quality of life.
What could go wrong
This is an early feasibility study with a small number of participants, so results may not apply to everyone. The program requires internet access and group participation, which may not suit all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

169 people

The number who actually took part.

Started

Sep 2021

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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, French or Spanish. * For the feasibility trial, eligible patients must be able to use the online intervention in English, and have low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) ≤ 7). * For the full-scale trial, eligible patients must be able to use the online intervention in English or French, and have low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) ≤ 7). Exclusion Criteria: * Patients not able to access or respond to questionnaires via the internet are excluded. * Participants who are currently participating in another SPIN intervention trial and have not yet completed their final assessment measures will be excluded. * French and Spanish speaking participants will be excluded from the feasibility trial. * Spanish speaking participants will be excluded from the full-scale trial. * Participants in the feasibility trial will be excluded in the full-scale trial.

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Conditions

The condition(s) this trial relates to.

diffuse scleroderma scleroderma systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Scleroderma Systemic sclerosis

Contacts and locations

Locations

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E3, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.