Nice University Hospital
Nice, 06000, France
NCT Number: NCT05388344
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.
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Notify Me18 year–99 year
All sexes
Observational
Nice, 06000, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Submission of the questionnaire before and after booklet reading
Time frame: 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
Time frame: day 1
Calculate the "Flesch Reading ease" index of the booklet
Time frame: day 1
Measurement of the impact of different variables, such as age, sex, pathology, on the questionnaire score by using statistical tests
Time frame: day 1
Calculation of the satisfaction rate by using a satisfaction survey
Time frame: day 1
number of responses
Centre Hospitalier Universitaire de Nice
Other
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
Acronym: LUMINA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.