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

NCT05388344 | Completed

• 1 other identifier: 21Neuro03
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Assess the booklet's lisibility

  day 1

• Assess the difference in understanding between patient groups

  day 1

• Measurement of the patients' satisfaction

  day 1

• Assess the booklet comprehension

  day 1

Interventions

Booklet reading OTHER

Submission of the questionnaire before and after booklet reading

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Participants unable to read
• Patient unable to understand the french language

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice University Hospital

Nice, 06000, France

Location

Study Officials

• Christine LEBRUN-FRENAY

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: May 24, 2022
• Study Start: October 15, 2021
• Primary Completion: November 15, 2021
• Study Completion: December 15, 2021
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)