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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

SPIN-SELF Trial 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.Check my eligibility

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.See study design

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.

SPIN-SELF Trial 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.

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I have been diagnosed with systemic sclerosis by a SPIN doctor.

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I am 18 years old or older.

SPIN-SELF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Participant Satisfaction: SPIN-SELF Program

Patient Activation Measure (PAM-13)

Patient Education Assessment Tool (PEMAT)

+4 more

SPIN-SELF 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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lady Davis InstituteLead Sponsor

44 Previous Clinical Trials

4,996 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies remaining for individuals to participate in the experiment?

"Per the clinicaltrials.gov website, this medical trial is presently recruiting volunteers and has been since September 15th 2021 (with an update on August 15th 2022)."

Answered by AI

How many participants does this research endeavor accept?

"Indeed, the clinicaltrials.gov database indicates that this medical trial is currently recruiting participants. It was initially posted on September 15th 2021 and last updated on August 15th 2022 with a goal of 524 patients from 1 site."

Answered by AI

Recent research and studies

TrialsJournal

The Scleroderma Patient-centered Intervention Network Self-management (SPIN-SELF) Program: Protocol for a Two-arm Parallel Partially Nested Randomized Controlled Feasibility Trial with Progression to Full-scale Trial

Nordlund, Julia, Richard S. Henry, Linda Kwakkenbos, Marie-Eve Carrier, Brooke Levis, Warren R. Nielson, Susan J. Bartlett, et al.. 2021. “The Scleroderma Patient-centered Intervention Network Self-management (SPIN-SELF) Program: Protocol for a Two-arm Parallel Partially Nested Randomized Controlled Feasibility Trial with Progression to Full-scale Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-021-05827-z.

clinicaltrials.govStudy

SPIN Self-Management Feasibility Trial With Progression to Full-scale Trial (SPIN-SELF)

Brett D Thombs 2021. "SPIN Self-Management Feasibility Trial With Progression to Full-scale Trial (SPIN-SELF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04246528.

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