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

Completed

• Conditions: Rheumatic

• Registration Number: NCT05388344
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-24
• Study Start: 2021-10-15
• Primary Completion: 2021-11-15
• Study Completion: 2021-12-15
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-23
• Last Update Submitted: 2022-05-23
• Study First Posted: 2022-05-24
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of the booklet	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nice University Hospital; 🇫🇷 Nice, France