SPIN-SELF Program for Scleroderma

(SPIN-SELF Trial)

No longer recruiting at 1 trial location

Overseen By Brett D Thombs, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lady Davis Institute

Disqualifiers: No internet access, Other SPIN trial, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online self-management program for people with scleroderma, a condition affecting the skin and organs. The SPIN-SELF Program includes videos and tools to help manage symptoms like pain, skin issues, sleep problems, and stress. Participants will either use this program or continue with their usual care to determine which is more effective in boosting confidence to manage the disease. Suitable candidates for this trial are those with scleroderma who have low confidence in managing their condition and can use online tools in English or French. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative research that may enhance self-management strategies for scleroderma.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on self-management techniques rather than medication changes.

What prior data suggests that the SPIN-SELF Program is safe for scleroderma patients?

Research has shown that the SPIN-SELF Program is generally safe for people with scleroderma. The program helps participants manage their condition through online materials and group sessions led by trained peers. This method has succeeded in other health programs without reports of serious side effects.

Earlier tests of the SPIN-SELF Program found no major safety issues. Participants attended educational sessions and learned ways to better handle symptoms like pain and tiredness. Since the program focuses on changing behaviors and peer support, rather than using medication, it is well-tolerated and doesn't cause physical side effects.

Although previous trials showed that not everyone participated actively, this doesn't affect safety. Instead, it highlights the need to make the program more engaging, which this trial aims to improve. Overall, evidence suggests that the SPIN-SELF Program is a safe choice for those looking to enhance their self-management skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SPIN-SELF Program is unique because it offers an online self-management tool specifically tailored for individuals with scleroderma. Unlike traditional treatments, which often focus on medication and physician-led interventions, the SPIN-SELF Program empowers patients to take an active role in managing their condition through self-guided resources and support. Researchers are excited about this approach because it could enhance patient autonomy and improve quality of life by providing tools that help manage symptoms and emotional well-being directly from home.

What evidence suggests that the SPIN-SELF Program is effective for managing scleroderma?

Research shows that the SPIN-SELF Program, which participants in this trial may receive, can help people with scleroderma, a long-term disease affecting connective tissues, manage their symptoms better. Studies have found that it boosts patients' confidence in handling their condition. This confidence, known as "self-efficacy," is crucial for dealing with everyday challenges. The program might also reduce worries about appearance and improve overall health and quality of life. It includes educational videos and group sessions that teach self-management techniques tailored to each person's symptoms. Overall, early findings suggest this approach could be helpful for people living with scleroderma. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can use the online program in English or French and feel unsure about managing my illness.

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

Patients must be able to give informed consent

Exclusion Criteria

French and Spanish speaking participants will be excluded from the feasibility trial

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Trial

Participants engage in an 8-session group videoconference intervention over 12 weeks to test the feasibility of the SPIN-SELF Program

12 weeks

8 group videoconference sessions

Full-scale Trial

Continuation to a full-scale randomized controlled trial to evaluate the SPIN-SELF Program's effectiveness

6 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• SPIN-SELF Program

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 Intervention

Access to the online SPIN-SELF program

Group II: Control group Active Control 1 Intervention

Usual care, no access to the online SPIN-SELF program

SPIN-SELF Program is already approved in Canada, United States, European Union for the following indications:

Approved in Canada as SPIN-SELF Program for:

• Self-management of systemic sclerosis (scleroderma) symptoms

Approved in United States as SPIN-SELF Program for:

• Self-management of systemic sclerosis (scleroderma) symptoms

Approved in European Union as SPIN-SELF Program for:

• Self-management of systemic sclerosis (scleroderma) symptoms

Who Is Running the Clinical Trial?

Lady Davis Institute

Lead Sponsor

Trials

50

Recruited

6,600+

Published Research Related to This Trial

The SPIN-SELF program, a web-based self-management tool for patients with systemic sclerosis (SSc), aims to enhance self-efficacy in disease management and improve health-related quality of life (HRQoL).

A feasibility trial involving 40 participants with low self-efficacy for managing their disease is underway to evaluate the implementation and acceptability of the SPIN-SELF program, which will inform future full-scale randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Scleroderma Patient-Centered Intervention Network Self-Management Program: Protocol for a Randomized Feasibility Trial. Carrier, ME., Kwakkenbos, L., Nielson, WR., et al.[2020]

The SPIN-SELF online self-management program for people with systemic sclerosis showed low engagement, with only 35% of participants consenting to use it and many accessing only a few modules, indicating a need for improved strategies to enhance user participation.

The study identified key feasibility issues that will inform the design of a full-scale randomized controlled trial, including the shift to a conventional trial design with pre-randomization consent and the addition of peer-facilitated videoconference groups to boost engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program. Kwakkenbos, L., Østbø, N., Carrier, ME., et al.[2022]

The Scleroderma Patient-centered Intervention Network (SPIN) aims to develop and test low-cost, self-guided online interventions to improve health-related quality of life for patients with systemic sclerosis, a rare disease, by recruiting 1500-2000 participants over five years.

Using a cohort multiple randomized controlled trial (cmRCT) design, SPIN will allow for ongoing data collection and comparison of outcomes between patients receiving interventions and those who do not, ensuring rigorous testing and effective dissemination of the interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Scleroderma Patient-centered Intervention Network (SPIN) Cohort: protocol for a cohort multiple randomised controlled trial (cmRCT) design to support trials of psychosocial and rehabilitation interventions in a rare disease context. Kwakkenbos, L., Jewett, LR., Baron, M., et al.[2022]

The SPIN-SSLED Programme, designed for support group leaders in scleroderma, was successfully delivered with high participant satisfaction (9.4/10) and minimal technical issues, indicating its feasibility for future trials.

Participants showed significant improvements in self-efficacy (1.7 SDs increase) and moderate reductions in burnout, emotional distress, and physical function, suggesting the programme effectively enhances the capabilities and well-being of support group leaders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scleroderma Patient-centered Intervention Network-Scleroderma Support group Leader EDucation (SPIN-SSLED) program: non-randomised feasibility trial. Thombs, BD., Dyas, L., Pépin, M., et al.[2023]

The SPIN-HAND online hand exercise program was successfully delivered in a feasibility trial involving 40 participants with scleroderma, demonstrating that the trial methodology functioned as intended.

However, only 63% of those offered the program consented to use it, and among those, only 33% engaged with the content more than twice, indicating a need for improved strategies to enhance participant acceptance and usage in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND). Kwakkenbos, L., Carrier, ME., Welling, J., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35219340/

Randomized feasibility trial of the Scleroderma Patient ... The aim of this study was to evaluate feasibility aspects for conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF Program.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03914781

NCT03914781 | SPIN Self-Management Feasibility Trial Analysis of outcome measures will include the completeness of data and presence of floor or ceiling effects. Descriptive statistics will be used to provide ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05827-z

The Scleroderma Patient-centered Intervention Network Self ... The SPIN-SELF Program may improve disease management self-efficacy, patient activation, social appearance anxiety, and functional health outcomes in people ...

4. ctv.veeva.com ctv.veeva.com/study/spin-self-management-feasibility-trial-with-progression-to-full-scale-trial-spin-self

SPIN Self-Management Feasibility Trial With Progression to ... The objectives of SPIN are (1) to assemble a large cohort of SSc patients who complete outcome assessments regularly in order to learn more ...

5. researchprotocols.org researchprotocols.org/2020/4/e16799/

The Scleroderma Patient-Centered Intervention Network ... Conclusions: The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL in patients with SSc.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03965780

The SPIN - Scleroderma Support Group Leader EDucation ... The aim of the SPIN-SSLED Trial is to assess the effectiveness of the SPIN-SSLED Program on scleroderma support group leaders' self-efficacy (primary outcome), ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34838105/

The Scleroderma Patient-centered Intervention Network ... The SPIN-SELF Program may improve disease management self-efficacy, patient activation, social appearance anxiety, and functional health outcomes in people ...