Evaluating Tools to Communicate Scleroderma Research Results to Patients - Trial #1 (SPIN-CLEAR #1)

A Randomized Controlled Trial to Compare the Effectiveness of Dissemination Tools to Share Research Results With Patients - SPIN-CLEAR Trial #1

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Sclerosis; Scleroderma
• Intervention / Treatment: Other: Dissemination Tool (Infographic); Other: Plain-language summary

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).

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brett D Thombs, PhD; Phone Number: 24244 514-340-8222; Email: brett.thombs@mcgill.ca
• Study Contact Backup: Name: Marie-Eve Carrier, MSc; Phone Number: 514-265-8676; Email: carrier.marie.eve@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dissemination tool (infographic); Infographic	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.
Active Comparator: Plain-language summary	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Open-ended items	"What did you like about the way the information was communicated?"; "What did you dislike about the way the information was communicated?"; "Do you have suggestions for improving how the information is communicated?"	Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)
Please to have received results	"I am glad that I received the study results"); 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)
Intention to participate in future studies	"In the future, I would agree to participate in a similar study to the one presented in the [tool]". 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)

Collaborators and Investigators

• Sponsor: Lady Davis Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 5, 2025
• Primary Completion (Estimated): December 19, 2025
• Study Completion (Estimated): January 2, 2026

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Intervention; Systemic Sclerosis; Knowledge Translation; Scleroderma; E-Health; Dissemination Tools
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: 2024-4165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data and materials will be provided upon reasonable requests to the corresponding author.
• IPD Sharing Time Frame: 12 months after the collection of the primary outcome.
• IPD Sharing Access Criteria: Approval of proposed purpose for data access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No