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NCT Number: NCT03105752

Evaluation of Readability of Consent Forms on the Understanding of the Information Received by Volunteers

Prior to the completion of biomedical research, any person undergoing it must receive a readable and intelligible information about this research, in order to give free and informed consent. The willingness to inform patients of all risks and constraints related to research may be in contradiction with the need to write informative and concise documents that are understandable to research participants. As a result, consent forms are long, contain a lot of information and are complicated to understand.

The objective of this study is to evaluate the impact of the readability of the information and consent forms on the understanding of the information received by participants in clinical trials.

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Key information

Conditions

Outcome Assessments (Health Care) Behavior Communication Comprehension Language

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Every volunteers included in a study in a french clinical research center
  • Ability to read and write in French

Exclusion criteria

  • Refusal of participation

Treatment and study plan

Questionnaire of understanding

Other

The study involved 12 clinical trials conducted in the Clinical Research Center Paris Est. Twenty participants per trial were offered to answer the "Qualité de Compréhension des Formulaires d'information et de consentement" questionnaire (QCFic) at the inclusion visit after receiving the information by the investigator and signed or refused to sign the form of consent.

Participants filled out the questionnaire in an isolated location, with no possibility of re-reading the information contained in the consent form. The questionnaire was immediately retrieved.

Primary outcomes

  1. Correlation between the overall comprehension score and the readability index of Flesch

    Time frame: Immediate evaluation

Secondary outcomes

  1. Correlation between the overall comprehension score and the level of education

    Time frame: Immediate evaluation

  2. Correlation between the overall comprehension score and the status of volunteer

    Time frame: Immediate evaluation

  3. Correlation between the overall comprehension score and the type of study

    Time frame: Immediate evaluation

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Official study title

Evaluation of the Readability of Information and Consent Forms on the Understanding of the Information Received by Participants in Biomedical Research

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 10, 2017
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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