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

Not Applicable

Completed

• Conditions: Outcome Assessments (Health Care); Comprehension; Language
• Interventions: Other: Questionnaire of understanding

• Registration Number: NCT03105752
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-04
• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-04
• Last Update Submitted: 2017-04-04
• Study First Posted: 2017-04-10
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Research participants	Questionnaire of understanding	Each participant of a clinical trial completed the "Qualité de Compréhension des Formulaires d'information et de consentement" questionnaire (QCFic) about its understanding of the information received. This questionnaire was retrieved immediately on the day of consent, with no possibility of referring to the content of information letter.

Primary Outcome Measures

Name	Time	Method
Correlation between the overall comprehension score and the readability index of Flesch	Immediate evaluation

Secondary Outcome Measures

Name	Time	Method
Correlation between the overall comprehension score and the type of study	Immediate evaluation
Correlation between the overall comprehension score and the level of education	Immediate evaluation
Correlation between the overall comprehension score and the status of volunteer	Immediate evaluation