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

ConditionsScleroderma Systemic Sclerosis

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorLady Davis Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Plain-language summary
Other intervention
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 intervention
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.

Treatment groups

128 Participants

are divided into 2 treatment groups

Group A: Dissemination tool (infographic)Experimental treatment 1 intervention

Group B: Plain-language summaryActive comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame