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临床试验/NCT05388344
NCT05388344已完成不适用

LUMINA : Measure the Effectiveness of the Booklet Named "Comprendre Les Essais Cliniques" With Patients Included or Not Included in Clinical Trials Within the Clinical Neurosciences - Rheumatology Pole of the CHU de Nice

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Evaluate the effectiveness of the booklet

研究概览

简要总结

Various studies have shown that many patients do not understand all the information provided by the study investigator and by the information sheet before entering a clinical research protocol. Many materials has been developped in previous research, trying to improve patients' understanding. Nonetheless, their effectiveness remains uncertain.

The "LUMINA" project aims to measure the effectiveness of the booklet named "Comprendre les essais cliniques" with patients included or not included in clinical trials within the Clinical Neurosciences - Rheumatology pole of the CHU de Nice. The design of this study is "before/after". A questionnaire was submitted to the patients before and after reading the booklet. That method is used in order to show if there was a difference between the score obtained from the questionnaire before and after reading. This difference could reflect an improvement in patients' comprehension and, by extension, the effectiveness of the support the team developed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient coming for a consultation or an hospitalization within the Clinical Neurosciences-Rheumatology pole of the CHU de Nice, or companions/caregivers who helps the patients understand
  • Patient able to read and to understand the french language,
  • Patient included or not in clinical trials.

排除标准

  • Participants unable to read
  • Patient unable to understand the french language

结局指标

主要结局

Evaluate the effectiveness of the booklet

时间窗: day 1

Measurement of the score (0 to 13)obtained from the assessment questionnaire (right or wrong) created for the study, before and after reading the booklet right = 1 point, wrong = 0 point . Score: points addition

次要结局

  • Assess the difference in understanding between patient groups(day 1)
  • Assess the booklet comprehension(day 1)
  • Assess the booklet's lisibility(day 1)
  • Measurement of the patients' satisfaction(day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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