Status:
COMPLETED
Impact of Readability Improvements on the Comprehension of Written Information Given to Clinical Trial Patients: a RCT
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Clinical Research Center of Grenoble
Clinical Research Center of Strasbourg
Conditions:
Comprehension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The principle objective of this randomised controlled trial is to assess whether an improvement in lexico-syntactic readability combined with adherence to French recommendations for good practice in w...
Detailed Description
The quality of written information given to people participating in clinical trials is essential as by law all volunteers have to be informed of a certain number of key elements. Those elements that a...
Eligibility Criteria
Inclusion
- Subject considered suitable to participate in one of the clinical trials selected for the LISYCOM study
- Age \> 18 years
Exclusion
- Illiteracy or inability to read French
- Neurological deficiency making reading impossible (attention disorders, aphasy, etc)
- Refusal to participate
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00908557
Start Date
April 1 2009
End Date
March 1 2014
Last Update
September 12 2014
Active Locations (1)
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1
Clinical Research Center, University Hospital Grenoble
Grenoble, France, 38043