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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Другое 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
• Другое 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.

Первичные конечные точки

• Completeness [Срок оценки: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)]
• Understandability [Срок оценки: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)]
• Ease of use [Срок оценки: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)]

Вторичные конечные точки (3)

• Please to have received results [Срок оценки: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)]
• Intention to participate in future studies [Срок оценки: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)]
• Open-ended items [Срок оценки: Immediately Post-intervention (intervention and outcomes in one login - outcomes approx 30 min after randomization)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

Patients not able to access or respond to questionnaires via the internet are excluded.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Thombs BD, Adams C, Nassar EL, Carrier ME, Golberg M, Bharthi K, Wurz A, South A, Kwakkenbos L, Hoa S, Rice DB, Guillot G, Lawrie-Jones A, Sauve M, Bartlett SJ, Fortune C, Gietzen A, Gottesman K, Hudson M, Hummers LK, Malcarne VL, Mayes MD, Richard M, Stempel J, Wojeck RK, Blagrave K, Boruff JT, Cook V, Culos-Reed N, Frobert O, Gillies K, Granikov V, Hemkens LG, Jimenez EY, Kocher A, Leite C, Lim PMID 40340935

Идентификаторы

NCT: NCT06373263 · 2024-4165

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗