NCT06373263

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Lady Davis Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2025-12-05
• Primary completion: 2025-12-19
• Completion: 2026-01-02
• First posted: 2024-04-18
• Last updated: 2025-12-08