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

NCT ID: NCT05388344

Last Updated: 2022-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-15

Study Completion Date

2021-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Booklet reading

Submission of the questionnaire before and after booklet reading

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine LEBRUN-FRENAY

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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Nice University Hospital

Nice, , France

Site Status

Countries

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France

Other Identifiers

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21Neuro03

Identifier Type: -

Identifier Source: org_study_id

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