Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Booklet reading | Other | Submission of the questionnaire before and after booklet reading |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Participants coming for a consultation or an hospitalization within the Clinical Neurosciences-Rheumatology pole of the CHU de Nice
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christine LEBRUN-FRENAY | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nice University Hospital | Nice | 06000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |