SPIN-SELF Program for Scleroderma

(SPIN-SELF Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Lady Davis Institute

Disqualifiers: No internet access, Other SPIN trial, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The Scleroderma Patient-centered Intervention Network (SPIN) is an organization established by researchers, health care providers, and people living with scleroderma (systemic sclerosis; SSc) from Canada, the United States, Mexico, Australia, France, Spain, and the United Kingdom. The objectives of SPIN are (1) to assemble a large cohort of SSc patients who complete outcome assessments regularly in order to learn more about important problems faced by people living with SSc and (2) to develop and test a series of internet-based interventions to help patients manage problems related to SSc, including a self-management program (SPIN-SELF Program). The SPIN-SELF Program was designed by SPIN members based on key tenets of behaviour change that have been successfully incorporated in programs for more common diseases and on patient input. It utilizes social modelling through educational videos of SSc patients describing their challenges and what they have done to cope with SSc, as well as videos teaching key self-management techniques. After an introduction to self-management and instructions on how to navigate the program, patients will have access to modules that are most relevant to their symptoms and disease management challenges. The program's modules address (1) pain; (2) skin care, finger ulcers, and Raynaud's; (3) sleep problems; (4) fatigue; (5) gastrointestinal symptoms; (6) itch; (7) emotions and stress; (8) body image concerns due to disfigurement; and (9) effective communication with healthcare providers. The proposed study is a feasibility trial with progression to full-scale randomized controlled trial (RCT), depending on whether stoppage criteria are met, of the SPIN Self-Management Program. The SPIN-SELF Program was previously feasibility tested as an online only, self-help intervention. However, uptake was low, thus the investigators have moved to a group-based format. SPIN-SELF participants randomized to intervention will access and use online self-management material, and this will be supported by videoconference group sessions, led by trained peer facilitators. In the SPIN-SELF feasibility trial with progression to full-scale trial, the investigators will evaluate the disease management self-efficacy of participants who use SPIN-SELF compared to usual care. Eligible SPIN Cohort participants and externally recruited participants, with low disease-management self-efficacy, will be randomized to the SPIN-SELF Program or to usual care only. In the feasibility portion, 40 eligible participants will be randomized. Unless the trial team determines, based on stoppage criteria, that trial procedures need important modifications thereby re-setting the full scale trial as a new trial, the outcome data of the participants in the feasibility portion will be utilized in the analyses of the full-scale trial. In the full-scale RCT, 524 participants will be randomized.

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 data supports the effectiveness of the SPIN-SELF treatment for scleroderma?

The SPIN-SELF program is designed to improve self-efficacy (confidence in managing one's own health) and quality of life for people with scleroderma. Self-management programs like SPIN-SELF have been shown to increase self-efficacy in managing chronic diseases, which can help improve overall well-being. ^{1 2 3 4 5}

How is the SPIN-SELF treatment for scleroderma different from other treatments?

The SPIN-SELF Program is unique because it is an online self-management program designed to improve patients' confidence in managing their scleroderma and enhance their quality of life, rather than focusing on medication or physical treatments. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

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 am fluent in English, French, or Spanish.

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

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

Trial Timeline

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

Treatment Details

Interventions

• SPIN-SELF Program (Behavioral Intervention)

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.

Participant Groups

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 for the following indications:

Approved in Canada 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+

Findings from Research

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 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]

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-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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND). [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

The Scleroderma Patient-Centered Intervention Network Self-Management Program: Protocol for a Randomized Feasibility Trial. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Scleroderma Patient-centered Intervention Network-Scleroderma Support group Leader EDucation (SPIN-SSLED) program: non-randomised feasibility trial. [2023]

5. England 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. [2022]