Impact of Readability Improvements on the Comprehension of Written Information Given to Clinical Trial Patients: a RCT

NACompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2014

Conditions
Comprehension
Interventions
OTHER

readability improvement and good practice redaction

improvement using Flesch readability index and good practice in redaction of informed consent documents.

OTHER

Control

information based on the classic informed consent document

Trial Locations (1)

38043

Clinical Research Center, University Hospital Grenoble, Grenoble

All Listed Sponsors
collaborator

Clinical Research Center of Grenoble

UNKNOWN

collaborator

Clinical Research Center of Strasbourg

UNKNOWN

collaborator

Hôpital Necker-Enfants Malades

OTHER

collaborator

Clinical Research Center of Lyon

UNKNOWN

collaborator

Clinical Research Center of Bichat, Paris

UNKNOWN

collaborator

Clinical Research Center of Saint-Etienne

UNKNOWN

collaborator

Clinical Research Center - biotherapy center of Saint-Louis, Paris

UNKNOWN

collaborator

Clinical Research Center of Clermont-Ferrand

UNKNOWN

collaborator

Clinical Research Center of Reunion island

UNKNOWN

collaborator

Clinical Research Center - Biotherapy center of Nantes

UNKNOWN

collaborator

CIC 1417 Cochin-Pasteur

OTHER

collaborator

Pharmacology unit of Créteil

UNKNOWN

collaborator

Clinical Research Center, Toulouse

OTHER

lead

University Hospital, Grenoble

OTHER