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

Sponsor
Lady Davis Institute
Study ID
NCT06373263
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 5, 2025
Status verified
Dec 2025
Primary completion
Dec 19, 2025
Completion
Jan 2, 2026

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Dissemination tool (infographic)
    Infographic
  • Active Comparator: Plain-language summary
    Plain-language summary

Primary Outcome Measure

Completeness [ Time Frame: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization) ]

Central Contacts

Related Studies