Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06373263 |
| Other study ID # |
2024-4165 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2024 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Lady Davis Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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. Analyses
will be intent-to-treat and use proportional odds regression models.
