Evaluation of Readability of Consent Forms on the Understanding of the Information Received by Volunteers
Not Applicable
Completed
- Conditions
- Outcome Assessments (Health Care)ComprehensionLanguage
- 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
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
- 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