LUMINA : Measure the Effectiveness of the Booklet Named Comprendre Les Essais Cliniques

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rheumatic

Intervention / Treatment
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* Other: Booklet reading


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age <18 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. Exclusion Criteria: Participants unable to read Patient unable to understand the french language

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Booklet reading|Submission of the questionnaire before and after booklet reading|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effectiveness of the booklet | 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 | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the booklet's lisibility | Calculate the Flesch Reading ease index of the booklet | day 1 | 
| Assess the difference in understanding between patient groups | Measurement of the impact of different variables, such as age, sex, pathology, on the questionnaire score by using statistical tests | day 1 | 
| Measurement of the patients' satisfaction | Calculation of the satisfaction rate by using a satisfaction survey | day 1 | 
| Assess the booklet comprehension | number of responses | day 1 |