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

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatic
• Intervention / Treatment: Other: Booklet reading

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Nice University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants coming for a consultation or an hospitalization within the Clinical Neurosciences-Rheumatology pole of the CHU de Nice

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Christine LEBRUN-FRENAY, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2021
• Primary Completion (ACTUAL): November 15, 2021
• Study Completion (ACTUAL): December 15, 2021

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (ACTUAL): May 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases
• Other Study ID Numbers: 21Neuro03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No