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NCT05388344: LUMINA

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

Completed Last updated 24 May 2022
What this trial tests

trial testing Booklet reading in Rheumatic in 50 participants. Completed in 15 December 2021.

Timeline
15 October 2021
Primary endpoint
15 November 2021
15 December 2021

Quick facts

Lead sponsorCentre Hospitalier Universitaire de Nice
StatusCompleted
Study typeOBSERVATIONAL
Enrollment50
Start date15 October 2021
Primary completion15 November 2021
Estimated completion15 December 2021
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

Adults 18 to 99, any sex, with Rheumatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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