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NCT03105752 Clinical Trial

Evaluation of Readability of Consent Forms on the Understanding of the Information Received by Volunteers

Language Clinical Trial

Official title:
Evaluation of the Readability of Information and Consent Forms on the Understanding of the Information Received by Participants in Biomedical Research

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03105752
Other study ID # CIC-1421-14-02
Secondary ID
Status Completed
Phase N/A
First received April 4, 2017
Last updated April 4, 2017
Start date April 2014
Est. completion date April 2016

Study information
Verified date April 2017
Source Groupe Hospitalier Pitie-Salpetriere
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prior to the completion of biomedical research, any person undergoing it must receive a readable and intelligible information about this research, in order to give free and informed consent. The willingness to inform patients of all risks and constraints related to research may be in contradiction with the need to write informative and concise documents that are understandable to research participants. As a result, consent forms are long, contain a lot of information and are complicated to understand.

The objective of this study is to evaluate the impact of the readability of the information and consent forms on the understanding of the information received by participants in clinical trials.

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Every volunteers included in a study in a french clinical research center

- Ability to read and write in French

Exclusion Criteria:

- Refusal of participation

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Questionnaire of understanding
The study involved 12 clinical trials conducted in the Clinical Research Center Paris Est. Twenty participants per trial were offered to answer the "Qualité de Compréhension des Formulaires d'information et de consentement" questionnaire (QCFic) at the inclusion visit after receiving the information by the investigator and signed or refused to sign the form of consent. Participants filled out the questionnaire in an isolated location, with no possibility of re-reading the information contained in the consent form. The questionnaire was immediately retrieved.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Groupe Hospitalier Pitie-Salpetriere

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between the overall comprehension score and the readability index of Flesch Immediate evaluation
Secondary Correlation between the overall comprehension score and the level of education Immediate evaluation
Secondary Correlation between the overall comprehension score and the status of volunteer Immediate evaluation
Secondary Correlation between the overall comprehension score and the type of study Immediate evaluation
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