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

Rheumatic Clinical Trial

— LUMINA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05388344
• Other study ID #: 21Neuro03
• Status: Completed
• Start date: October 15, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Rheumatic
• Rheumatic Diseases

Intervention

Other:
• Booklet reading
Submission of the questionnaire before and after booklet reading

Locations

Country	Name	City	State
France	Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assess the booklet's lisibility	Calculate the "Flesch Reading ease" index of the booklet	day 1
Secondary	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
Secondary	Measurement of the patients' satisfaction	Calculation of the satisfaction rate by using a satisfaction survey	day 1
Secondary	Assess the booklet comprehension	number of responses	day 1