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

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 writing the Information and Consent Form (ICF) given to patients participating in clinical trials, increases their understanding of the information compared to conventional written information, in real (not simulated) conditions.

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

Sponsors & Collaborators

• Clinical Research Center of Grenoble

  collaborator UNKNOWN

• Clinical Research Center of Strasbourg

  collaborator UNKNOWN

• Hôpital Necker-Enfants Malades

  collaborator OTHER

• Clinical Research Center of Lyon

  collaborator UNKNOWN

• Clinical Research Center of Bichat, Paris

  collaborator UNKNOWN

• Clinical Research Center of Saint-Etienne

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• Clinical Research Center of Clermont-Ferrand

  collaborator UNKNOWN

• Clinical Research Center of Reunion island

  collaborator UNKNOWN

• Clinical Research Center - Biotherapy center of Nantes

  collaborator UNKNOWN

• CIC 1417 Cochin-Pasteur

  collaborator OTHER

• Pharmacology unit of Créteil

  collaborator UNKNOWN

• Clinical Research Center, Toulouse

  collaborator OTHER

• University Hospital, Grenoble

  lead OTHER

Principal Investigators

• Jean-Luc CRACOWSKI, MD · Clinical Research Center Grenoble France

Study Design

Allocation

RANDOMIZED

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-04-30

Primary Completion

2013-03-31

Completion

2014-03-31

Countries

• France

Study Locations