Evaluating Tools to Communicate Scleroderma Research Results to Patients - Trial #1

NCT06373263 | Not Yet Recruiting DMC

• 1 other identifier: 2024-4165
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sharing research results with patients is required by ethical regulations. Yet, most researchers do not share results from their studies with patients. The investigators plan to conduct a series of randomized controlled trials among people with scleroderma, a rare autoimmune disease, in a large international cohort, to identify the most effective methods for communicating study results with patients. The first trial in the series will compare a research dissemination tool (infographic) against a plain-language summary comparator. Participants will be randomly assigned to receive the dissemination tool or comparator. Study participants will rate communication tools for (1) information completeness; (2) understandability; and (3) ease of use of format. Our results can be used by researchers and patient organizations who disseminate research results so that they can tailor the way they disseminate results to patient needs.

Conditions

Scleroderma; Systemic Sclerosis

Keywords

Scleroderma; Knowledge Translation; Dissemination Tools; E-Health; Intervention; Systemic Sclerosis

Outcome Measures

Primary Outcomes (3)

• Completeness

  "The information presented in the \[tool - e.g., "infographic", "plain-language summary"\] told me everything I wanted to know about the study". Response options = 0-10 numerical rating scales (0 = strongly disagree, 10 = strongly agree)

  Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)

• Understandability

  "The information presented in the \[tool\] was easy to understand". Response options = 0-10 numerical rating scales (0 = strongly disagree, 10 = strongly agree)

  Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)

• Ease of use

  "The \[tool\] was designed in a way that made it easy to use". Response options = 0-10 numerical rating scales (0 = strongly disagree, 10 = strongly agree)

  Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)

Secondary Outcomes (3)

• Please to have received results

  Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)

• Intention to participate in future studies

  Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)

• Open-ended items

  Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)

Study Arms (2)

Dissemination tool (infographic)

EXPERIMENTAL

Infographic

Other: Dissemination Tool (Infographic)

Plain-language summary

ACTIVE COMPARATOR

Plain-language summary

Other: Plain-language summary

Interventions

Plain-language summary OTHER

Participants will receive information about a research study via a plain-language summary. The comparator will be a plain-language summary, since plain-language summaries are commonly used and more easily developed than other tools. The summary will be designed based on Canadian government and other key recommendations, including from the Cochrane Collaboration. It will include Background and Objectives, Methods, Results, Limitations, and Key Message for Patients sections and include information on how evidence informs knowledge or health care options. Abstract will be \< 500 words long and use short, positive, active-voice sentence structures and everyday words. Reading level will be between 8th and 9th grade based on Flesch-Kincaid Grade Level and readability score between 60 and 70 based on Flesch Reading Ease.

Plain-language summary

Dissemination Tool (Infographic) OTHER

The infographic will be developed based on key principles including clearly defining the audience and purpose; sharing a story, rather than just facts, with brief, clear messaging; highlighting main ideas; using an attractive title and images; and following principles of good graphic design.

Dissemination tool (infographic)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrollment in SPIN Cohort, which requires a systemic sclerosis (SSc) classification by a site physician based on 2013 American College of Rheumatology/European League Against Rheumatism criteria, ≥18 years old, being fluent in English or French, and have completed one SPIN Cohort assessment in the last year.
• External enrollment with patient-reported physician classification of SSc and age 18 or older.

You may not qualify if:

• Patients not able to access or respond to questionnaires via the internet are excluded.

Sponsors & Collaborators

• Lady Davis Institute: lead

Related Publications (1)

• Thombs BD, Adams C, Nassar EL, Carrier ME, Golberg M, Bharthi K, Wurz A, South A, Kwakkenbos L, Hoa S, Rice DB, Guillot G, Lawrie-Jones A, Sauve M, Bartlett SJ, Fortune C, Gietzen A, Gottesman K, Hudson M, Hummers LK, Malcarne VL, Mayes MD, Richard M, Stempel J, Wojeck RK, Blagrave K, Boruff JT, Cook V, Culos-Reed N, Frobert O, Gillies K, Granikov V, Hemkens LG, Jimenez EY, Kocher A, Leite C, Lim MAWT, Maltez N, Michalski J, Mieszczak T, Ndosi M, Pope J, Rannou F, Rozee K, Straus SE, Sydes MR, Thabane L, Varga J, Yap T, Zwarenstein M, Mouthon L, Benedetti A; SPIN Investigators. Master protocol for a series of cohort-based randomized controlled trials to test tools to communicate research results to study participants and others with relevant lived experience: the SPIN-CLEAR Trials. Trials. 2025 May 8;26(1):149. doi: 10.1186/s13063-025-08846-2.

  PMID: 40340935 BACKGROUND

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Brett D Thombs, PhD

CONTACT

514-340-8222; brett.thombs@mcgill.ca

Marie-Eve Carrier, MSc

CONTACT

514-265-8676; carrier.marie.eve@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: December 5, 2025
• Primary Completion: December 19, 2025
• Study Completion: January 2, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months after the collection of the primary outcome.
• Access Criteria: Approval of proposed purpose for data access.