Outcome Assessments (Health Care)NCT03105752
Evaluation of Readability of Consent Forms on the Understanding of the Information Received by Volunteers
A study testing Questionnaire of understanding in people with Outcome Assessments (Health Care) and Comprehension, run by Groupe Hospitalier Pitie-Salpetriere.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Outcome Assessments (Health Care), Comprehension, Language
- What is being tested?
- Questionnaire of understanding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Every volunteers included in a study in a french clinical research center
- Ability to read and write in French
Who cannot join
- Refusal of participation
About this study
Official title: Evaluation of the Readability of Information and Consent Forms on the Understanding of the Information Received by Participants in Biomedical Research
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
- Being tested
- Questionnaire of understanding
- Keywords
- Outcome Assessments (Health Care), Volunteers, Informed consent, Comprehension, Language tests
- Medical subject headings
- Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire of understandingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire of understanding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the overall comprehension score and the readability index of Flesch
Measured: Immediate evaluation
Secondary outcomes (3)
Correlation between the overall comprehension score and the level of education
Measured: Immediate evaluation
Correlation between the overall comprehension score and the status of volunteer
Measured: Immediate evaluation
Correlation between the overall comprehension score and the type of study
Measured: Immediate evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study startApr 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outcome Assessments (Health Care)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
- Investigators
- Christian Funck-Brenta, MD, PhD, Study director, Centre d'investigation clinique Paris Est
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105752
- Sponsor's protocol ID
- CIC-1421-14-02
- Status last verified
- Apr 2017
- First submitted
- 4 Apr 2017
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Readability of Information and Consent Forms on the Understanding of the Information Received by Participants in Biomedical Research
- ClinicalTrials.gov ID
- NCT03105752
- Acronym / sponsor ID
- CIC-1421-14-02
- Conditions
- Outcome Assessments (Health Care), Comprehension, Language
- Keywords
- Outcome Assessments (Health Care), Volunteers, Informed consent, Comprehension, Language tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research participants | Experimental | Other: Questionnaire of understandingEach 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Every volunteers included in a study in a french clinical research center
- Ability to read and write in French
Key exclusion criteria (1 listed)
- Refusal of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire of understandingThe 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. | Other | Research participants |
Primary outcome
Correlation between the overall comprehension score and the readability index of Flesch
Time frame: Immediate evaluation
3 secondary outcomes
Correlation between the overall comprehension score and the level of education
Time frame: Immediate evaluation
Correlation between the overall comprehension score and the status of volunteer
Time frame: Immediate evaluation
Correlation between the overall comprehension score and the type of study
Time frame: Immediate evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Funck-Brenta, MD, PhD study director
Centre d'investigation clinique Paris Est
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire of understanding in people with Outcome Assessments (Health Care) and Comprehension, run by Groupe Hospitalier Pitie-Salpetriere.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the overall comprehension score and the readability index of Flesch (time frame: Immediate evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017; AzTrials last refreshed its copy on 6 Nov 2026.