Evaluation of the Information of the Patient Before a Scheduled Coronarography (INFOCORO)

October 13, 2016 updated by: French Cardiology Society
French study, multicentrique with the cooperation of several hospital centers . 700 patients (200 in the stage 1 and 500 in the stage 2). Every patient will complete questionnaires in a anonymous way.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Stage 1: evaluation of the score in the population and the evaluation of the improvement of the score after an information more detailed by the educational video.

For that purpose, inclusion on one week with comparison of the score obtained during a classic information with delivery of the sheet of information and during a classic information followed by an information more detailed with educational video.

Check during this stage of the significant improvement of the score with the addition of the educational video literally of information and in the oral information supplied usually within the framework of the current care Evaluation of the number of subject included in the 1 week. Stage 2: Comparison of the patient understanding between 2 groups: 1 group received the information by using the information targeted with educational video (modern information) and the other group the classic information considered as the reference.

Inclusion planned over 2 weeks with for every center 1 week of classic information and 1 week of targeted information, allowing a randomized comparison of the 2 methods.

To limit the biases of inclusions and the effect centers, every center will realize 1 week of every method, according to a specific drawing lots in every center to determine with which information (classic or targeted) the study will begin.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
821

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • CHU Amiens
      • Besançon, France, 25030
        • Chu Jean Minjoz
      • Bobigny, France
        • CHU Avicennes
      • Brest, France
        • CHU Brest
      • Bron, France
        • Hôpital cardiologique Louis Pradel
      • Chartres, France
        • CH Chartres
      • Clermont Ferrand, France
        • Hôpital Gabriel Montpied
      • Crétail, France
        • CHU Mondor
      • Dijon, France
        • CHU Dijon
      • Grenoble, France
        • CHU Grenoble
      • Jossigny, France
        • CH Lagny
      • Le Mans, France
        • CH Mans
      • Lille, France
        • CHRU Lille
      • Macon, France
        • CH
      • Marseille, France
        • CHU Marseille
      • Metz-tessy, France
        • CH d'Annecy-genevois
      • Montfermeil, France
        • Groupe intercommunal Le Raincy Montfermeil
      • Montpellier, France
        • CHRU
      • Montreuil-sous-bois, France
        • CHI André Grégoire
      • Nantes, France
        • CHU Nord LAENNEC
      • Neuilly Sur Seine, France
        • Clinique Ambroise Pare
      • Nimes, France
        • CHU Nimes
      • Paris, France, 75013
        • CHU Pitie Salpetriere
      • Paris, France
        • Chu Saint Antoine
      • Paris, France, 75015
        • European Georges Pompidou Hospital
      • Paris, France
        • BICHAT
      • Paris, France
        • CHU Ambroise Pare
      • Paris, France
        • COCHIN
      • Paris, France
        • Lariboisière
      • Perpignan, France
        • CH Perpignan
      • Pessac, France
        • Hôpital Cardiologique Haut Lévêque
      • Poitiers, France
        • CHU Poitiers
      • Reims, France
        • Chu Reims
      • Rennes, France, 35000
        • Chu Rennes
      • Saint Brieuc, France
        • CH Yves Le Foll
      • Saint-Denis, France, 93200
        • Centre Cardiologique du Nord
      • Strasbourg, France
        • CHU Strasbourg
      • Toulouse, France, 31059
        • CHU TOULOUSE Rangueil
      • Tours, France
        • Hôpital Trousseau
      • Vandoeuvre Les Nancy, France
        • Chru Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with scheduled coronarography

Description

Inclusion Criteria:

  • hospitalisation for scheduled coronarography

Exclusion Criteria:

  • Coronarographies with general anesthesia.
  • Patients not speaking or not reading French, or having linguistic knowledge not allowing the delivery of an appropriate information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients receive usual information
Patients receive usual information before Scheduled Coronarography
Other: usual information
usual information for coronarography
patients receive modern information
Patients receive usual information and a information by video before Scheduled Coronarography
Other: usual information
usual information for coronarography
Other: modern information
information by video for coronarography

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improvement of the quality of the information of the patients
Time Frame: one day
Improvement of the quality of the information of the patients by a video about the coronarography (realization of the procedure, the profits and the risks) associated with a written information. The quality of the information will be estimated by a dedicated score.
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
French Cardiology Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-04 (BOOG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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