NCT00908557

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

3.9 years

First QC Date

May 26, 2009

Last Update Submit

September 11, 2014

Conditions

Comprehension

Keywords

Lexicosyntactic readability improvementphase II/III trialsethicInformed consent

Outcome Measures

Primary Outcomes (1)

  • Sub-score in part A (objective comprehension) of the QECIEM questionnaire of comprehension.

    24 hours

Secondary Outcomes (7)

  • Total score in the QECIEM questionnaire of comprehension.

    24 hours

  • Sub-scores in part B (subjective comprehension) of questionnaire of comprehension.

    24 hours

  • Adhesion to proposed clinical trial protocols

    end of the study or end of Lisycom

  • Impact of complementary oral information on the QECIEM scores

    24 hours

  • Subjective evaluation of readability by the investigator

    begin of the study or begin of Lisycom

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Patients receiving an information and consent form that has been modified using the LISYCOM methods.

Other: readability improvement and good practice redaction

2

ACTIVE COMPARATOR

Patients receiving a standard information and consent form.

Other: Control

Interventions

readability improvement and good practice redactionOTHER

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

1
ControlOTHER

information based on the classic informed consent document

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Illiteracy or inability to read French
  • Neurological deficiency making reading impossible (attention disorders, aphasy, etc)
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center, University Hospital Grenoble

Grenoble, 38043, France

Location

Related Publications (5)

  • Paris A, Cracowski JL, Ravanel N, Cornu C, Gueyffier F, Deygas B, Guillot K, Bosson JL, Hommel M. [Readability of informed consent forms for subjects participating in biomedical research: updating is required]. Presse Med. 2005 Jan 15;34(1):13-8. doi: 10.1016/s0755-4982(05)83877-1. French.

    PMID: 15685092BACKGROUND

  • Paris A, Cracowski JL, Maison P, Radauceanu A, Cornu C, Hommel M. Impact of French 'Comites de Protection des Personnes' on the readability of informed consent documents (ICD) in biomedical research: more information, but not better information. Fundam Clin Pharmacol. 2005 Jun;19(3):395-9. doi: 10.1111/j.1472-8206.2005.00327.x.

    PMID: 15910664BACKGROUND

  • Okais C, Paris A, Cracowski JL. [Readability and information density in biomedical research]. Therapie. 2007 Jan-Feb;62(1):17-21. doi: 10.2515/therapie:2007008. Epub 2007 Mar 21. French.

    PMID: 17374343BACKGROUND

  • Paris A, Cornu C, Auquier P, Maison P, Radauceanu A, Brandt C, Salvat-Melis M, Hommel M, Cracowski JL. French adaptation and preliminary validation of a questionnaire to evaluate understanding of informed consent documents in phase I biomedical research. Fundam Clin Pharmacol. 2006 Feb;20(1):97-104. doi: 10.1111/j.1472-8206.2005.00391.x.

    PMID: 16448400BACKGROUND

  • Paris A, Nogueira da Gama Chaves D, Cornu C, Maison P, Salvat-Melis M, Ribuot C, Brandt C, Bosson JL, Hommel M, Cracowski JL. Improvement of the comprehension of written information given to healthy volunteers in biomedical research: a single-blind randomized controlled study. Fundam Clin Pharmacol. 2007 Apr;21(2):207-14. doi: 10.1111/j.1472-8206.2007.00472.x.

    PMID: 17391294BACKGROUND

Study Officials

  • Jean-Luc CRACOWSKI, MD

    Clinical Research Center Grenoble France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pr Jean-Luc CRACOWSKI

Study Record Dates

First Submitted

May 26, 2009

First Posted

May 27, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2014

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations

FR(1)