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

NCT ID: NCT06373263

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-05
• Study Completion Date: 2026-01-02

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.

Detailed Description

Background: Research ethics guidance mandates that study results be shared with participants, and CIHR's Knowledge Translation Strategy emphasizes dissemination to others with relevant lived experiences. Yet, most researchers do not share results with patients, and do not know which dissemination tools (e.g., lay summaries, infographics, podcasts) or tool features best facilitate effective communication. Only 3 randomized controlled trials (RCTs) have compared tool effectiveness, and none assessed which approaches work best for which patients. Comparative effectiveness trials are needed to build an evidence base to help us understand what tools are most effective for communicating different types of research to different patients. The investigators will use the multinational Scleroderma Patient-centered Intervention Network (SPIN) Cohort to conduct a series of RCTs to compare tools among people with systemic sclerosis, or scleroderma. The first trial in the series will compare a research dissemination tool (infographic) against a plain-language summary comparator.

Objectives: An effective tool must communicate information patients want to know, understandably, in an easy-to-use format. The trial will compare the effectiveness of an infographic and lay summary, overall and for patients with different sociodemographic or educational characteristics.

Primary Objectives: The first trial will compare tools based on (1) information completeness; (2) understandability; and (3) ease of use, as prioritized by our Patient Advisory Team.

Secondary Objectives: The investigators will evaluate comprehension of key aspects of disseminated research; likelihood that participants would enroll in a similar future study; and, for all primary and secondary outcomes, analyze effects by participant characteristics (e.g., age, country, language, education level, eHealth literacy).

Methods: Parallel-group RCT that will compare 2 tools (infographic and plain-language summary comparator. For this trial, SPIN patients and researchers will select systemic sclerosis research to disseminate. Tools will be developed by experienced tool developers, patients, and researchers. SPIN Cohort participants (N = 1,250 and growing) will be invited to enrol, and those enrolled will be randomized to a dissemination tool and complete outcomes. Response options will be 0 to 10 numerical rating scales (0 = strongly disagree, 10 = strongly agree). The primary analysis will be intention-to-treat, using a linear mixed effects model with multiple observations per participant (using the lmer function from the lme4 package in R).

Conditions

Scleroderma; Systemic Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dissemination tool (infographic)

Infographic

Group Type: EXPERIMENTAL

Dissemination Tool (Infographic)

Intervention Type: 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.

Plain-language summary

Plain-language summary

Group Type: ACTIVE_COMPARATOR

Plain-language summary

Intervention Type: 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.

Interventions

Plain-language summary

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.

Intervention Type: OTHER

Dissemination Tool (Infographic)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 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.

2. External enrollment with patient-reported physician classification of SSc and age 18 or older.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lady Davis Institute

OTHER

Sponsor Role: lead

Responsible Party

Brett D Thombs

Senior Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Brett D Thombs, PhD

Role: CONTACT

brett.thombs@mcgill.ca

514-340-8222 ext. 24244

Marie-Eve Carrier, MSc

Role: CONTACT

carrier.marie.eve@gmail.com

514-265-8676

References

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.

Reference Type: BACKGROUND

PMID: 40340935 (View on PubMed)

Other Identifiers

2024-4165

Identifier Type: -

Identifier Source: org_study_id