Online self-management program for scleroderma patients
The Scleroderma Patient-centered Intervention Network (SPIN) Self-Management Program: Protocol for a Randomised Controlled Feasibility Trial With Progression to Full-Scale Trial
NA · Lady Davis Institute · NCT04246528
This study is testing an online program to help people with scleroderma manage their condition better by sharing experiences and tips from other patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 524 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lady Davis Institute (other) |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT04246528 on ClinicalTrials.gov |
What this trial studies
The SPIN-SELF program aims to evaluate the effectiveness of an internet-based self-management intervention for patients with systemic sclerosis (scleroderma). This program is designed based on patient input and behavior change principles, utilizing educational videos featuring real patients sharing their experiences. The primary goal is to enhance disease management self-efficacy among participants compared to usual care, while secondary objectives include assessing patient activation, social appearance anxiety, functional health outcomes, and overall satisfaction with the program. The trial will recruit eligible patients from a large cohort of scleroderma patients across multiple countries.
Who should consider this trial
Good fit: Ideal candidates are adults with a confirmed diagnosis of systemic sclerosis who have low self-efficacy in managing their disease.
Not a fit: Patients who are unable to access the internet or participate in online interventions may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve self-management skills and health outcomes for patients with scleroderma.
How similar studies have performed: Other studies have shown promise in using online interventions for chronic disease management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Montréal, Quebec
- Jewish General Hospital — Montréal, Quebec, Canada (RECRUITING)
Study contacts
- Study coordinator: Brett D Thombs, PhD
- Email: brett.thombs@mcgill.ca
- Phone: 514-340-8222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Scleroderma, Systemic Sclerosis, Self-management, E-health, Intervention