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

NCT06373263 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-12-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Lady Davis Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-05
Primary Completion
2025-12-19
Completion
2026-01-02

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06373263 on ClinicalTrials.gov