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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Clinical Research Center of Grenoble
Clinical Research Center of Strasbourg
Hôpital Necker-Enfants Malades
Clinical Research Center of Lyon
Clinical Research Center of Bichat, Paris
Clinical Research Center of Saint-Etienne
Clinical Research Center - biotherapy center of Saint-Louis, Paris
Clinical Research Center of Clermont-Ferrand
Clinical Research Center of Reunion island
Clinical Research Center - Biotherapy center of Nantes
Clinical Research Center - Vacine center of Cochin - Pasteur, Paris
Pharmacology unit of Créteil
Clinical Research Center of Toulouse
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00908557
First received: May 26, 2009
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Comprehension
Other: readability improvement and good practice redaction
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Multicenter RCT to Assess the Impact of Improvements in Lexico-syntactic Readability and Good Practice in Writing on the Comprehension of Written Information Given to Patients Participating in Clinical Trials.

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Sub-score in part A (objective comprehension) of the QECIEM questionnaire of comprehension. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total score in the QECIEM questionnaire of comprehension. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Sub-scores in part B (subjective comprehension) of questionnaire of comprehension. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Adhesion to proposed clinical trial protocols [ Time Frame: end of the study or end of Lisycom ] [ Designated as safety issue: No ]
  • Impact of complementary oral information on the QECIEM scores [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Subjective evaluation of readability by the investigator [ Time Frame: begin of the study or begin of Lisycom ] [ Designated as safety issue: No ]
  • Number of refusals to sign informed consent form for the proposed trial. [ Time Frame: end of the study or end of Lisycom ] [ Designated as safety issue: No ]
  • Score of the QECIEMc [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2009
Estimated Study Completion Date: March 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients receiving an information and consent form that has been modified using the LISYCOM methods.
Other: readability improvement and good practice redaction
improvement using Flesch readability index and good practice in redaction of informed consent documents.
Active Comparator: 2
Patients receiving a standard information and consent form.
Other: Control
information based on the classic informed consent document

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 are necessary to understanding and making a decision as to whether to participate in the trial are presented to the volunteer in the information and consent document (ICD).

Many terms used in the ICD are of necessity medical terms and sometimes difficult to understand for the person who may participate in the study.

Several factors are involved when a reader receives a text, and one of the difficulties of intelligibility can be the lexico-syntactic readability.

The lexico-syntactic readability is the only element of intelligibility that can be readily quantified, using the Flesch-Kincaid index. It is also an element that can be very easily modified without changing the sense of the information.

In the QuIP-3 study, which we performed in 2003, it appeared that the lexico-syntactic readability of ICF is very low, lower than that of texts used in university level classics examinations. Furthermore, there is no correlation between the density of information and readability (QuIP-5 study).

It seems to be necessary to assess the understanding of those participating in clinical trials in terms of logical and cognitive intelligibility (representativeness and interpretability of the information and consent forms). Indeed, a text may be unreadable according to the Flesch score, in lexico-syntactic terms, but perfectly understood and interpreted.

As no questionnaire had been validated in French, we validated the " Questionnaire d'Evaluation de la Compréhension de l'Information Ecrite par les Malades or QECIEM " (Questionnaire measuring patient comprehension of written information) (QuIP-4). This questionnaire can be used to measure both objective and subjective general understanding by a patient to be included in a therapeutic study, irrespective of the pathology.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject considered suitable to participate in one of the clinical trials selected for the LISYCOM study
  • Age > 18 years

Exclusion Criteria:

  • Illiteracy or inability to read French
  • Neurological deficiency making reading impossible (attention disorders, aphasy, etc)
  • Refusal to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908557

Locations
France
Clinical Research Center, University Hospital Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Clinical Research Center of Grenoble
Clinical Research Center of Strasbourg
Hôpital Necker-Enfants Malades
Clinical Research Center of Lyon
Clinical Research Center of Bichat, Paris
Clinical Research Center of Saint-Etienne
Clinical Research Center - biotherapy center of Saint-Louis, Paris
Clinical Research Center of Clermont-Ferrand
Clinical Research Center of Reunion island
Clinical Research Center - Biotherapy center of Nantes
Clinical Research Center - Vacine center of Cochin - Pasteur, Paris
Pharmacology unit of Créteil
Clinical Research Center of Toulouse
Investigators
Principal Investigator: Jean-Luc CRACOWSKI, MD Clinical Research Center Grenoble France
  More Information

Publications:
Responsible Party: AdministrateurCIC, Pr Jean-Luc CRACOWSKI, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00908557     History of Changes
Other Study ID Numbers: DCIC 08 15
Study First Received: May 26, 2009
Last Updated: July 17, 2013
Health Authority: France: Institutional Ethical Committee

Keywords provided by University Hospital, Grenoble:
Lexicosyntactic readability improvement
phase II/III trials
ethic
Informed consent

ClinicalTrials.gov processed this record on July 28, 2014