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SPIN-SELF Program for Scleroderma (SPIN-SELF Trial)

N/A
Recruiting
Research Sponsored by Lady Davis Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Patients must be fluent in English, French or Spanish
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will help researchers learn more about how to manage scleroderma, a disease which causes the hardening and tightening of the skin and connective tissues.

Who is the study for?
This trial is for adults with systemic sclerosis who can consent, speak English (and French or Spanish for the full-scale trial), and have low confidence in managing their disease. They must be able to use online tools but not be part of another SPIN intervention awaiting assessment.
What is being tested?
The SPIN-SELF Program, an internet-based self-management program supported by videoconference group sessions, is being tested against usual care. It aims to improve how patients manage symptoms like pain, skin issues, fatigue, and emotional stress.
What are the potential side effects?
Since this is a non-drug intervention focusing on education and self-management through online modules and peer support groups, traditional side effects are not expected. However, participants may experience discomfort or frustration if they find the technology challenging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can use the online program in English or French and feel unsure about managing my illness.
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I am fluent in English, French, or Spanish.
Select...
I have been diagnosed with systemic sclerosis by a SPIN doctor.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Participant Satisfaction: SPIN-SELF Program
Patient Activation Measure (PAM-13)
Patient Education Assessment Tool (PEMAT)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
Access to the online SPIN-SELF program
Group II: Control groupActive Control1 Intervention
Usual care, no access to the online SPIN-SELF program
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SPIN-SELF Program
2019
N/A
~40

Find a Location

Who is running the clinical trial?

Lady Davis InstituteLead Sponsor
48 Previous Clinical Trials
5,644 Total Patients Enrolled
6 Trials studying Scleroderma
1,216 Patients Enrolled for Scleroderma

Media Library

SPIN-SELF Program Clinical Trial Eligibility Overview. Trial Name: NCT04246528 — N/A
Scleroderma Research Study Groups: Intervention group, Control group
Scleroderma Clinical Trial 2023: SPIN-SELF Program Highlights & Side Effects. Trial Name: NCT04246528 — N/A
SPIN-SELF Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04246528 — N/A
~109 spots leftby Oct 2025
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