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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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
        • Hopital 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 Nîmes
      • Paris, France, 75013
        • CHU Pitié Salpétrière
      • Paris, France
        • CHU Saint Antoine
      • Paris, France, 75015
        • European Georges Pompidou Hospital
      • Paris, France
        • Bichat
      • Paris, France
        • CHU Ambroise Paré
      • Paris, France
        • Cochin
      • Paris, France
        • Lariboisiere
      • Perpignan, France
        • Ch Perpignan
      • Pessac, France
        • Hopital Cardiologique Haut Lévèque
      • 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

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
Intervention / Treatment
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

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

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

July 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

June 29, 2015

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-04 (Other Identifier: 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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