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Completed

NCT Number: NCT05388344

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

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.

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nice University Hospital

Nice, 06000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Booklet reading

Other

Submission of the questionnaire before and after booklet reading

Primary outcomes

  1. Evaluate the effectiveness of the booklet

    Time frame: day 1

    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

Secondary outcomes

  1. Assess the booklet's lisibility

    Time frame: day 1

    Calculate the "Flesch Reading ease" index of the booklet

  2. Assess the difference in understanding between patient groups

    Time frame: day 1

    Measurement of the impact of different variables, such as age, sex, pathology, on the questionnaire score by using statistical tests

  3. Measurement of the patients' satisfaction

    Time frame: day 1

    Calculation of the satisfaction rate by using a satisfaction survey

  4. Assess the booklet comprehension

    Time frame: day 1

    number of responses

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: LUMINA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 24, 2022
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.