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

NCT03105752 | Completed

• 1 other identifier: CIC-1421-14-02
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Outcome Assessments (Health Care); Comprehension; Language

Keywords

Outcome Assessments (Health Care); Volunteers; Informed consent; Comprehension; Language tests

Outcome Measures

Primary Outcomes (1)

• Correlation between the overall comprehension score and the readability index of Flesch

  Immediate evaluation

Secondary Outcomes (3)

• Correlation between the overall comprehension score and the level of education

  Immediate evaluation

• Correlation between the overall comprehension score and the status of volunteer

  Immediate evaluation

• Correlation between the overall comprehension score and the type of study

  Immediate evaluation

Study Arms (1)

Research participants

EXPERIMENTAL

Each participant of a clinical trial completed the "Qualité de Compréhension des Formulaires d'information et de consentement" questionnaire (QCFic) about its understanding of the information received. This questionnaire was retrieved immediately on the day of consent, with no possibility of referring to the content of information letter.

Other: Questionnaire of understanding

Interventions

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.

Research participants

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Refusal of participation

Sponsors & Collaborators

• Groupe Hospitalier Pitie-Salpetriere: lead

MeSH Terms

Conditions

Language

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Officials

• Christian Funck-Brenta, MD, PhD

  Centre d'investigation clinique Paris Est

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 10, 2017
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 10, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share