Evaluation of the Information of the Patient Before a Scheduled Coronarography

NCT ID: NCT02484144

Last Updated: 2016-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

821 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiac Disease

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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patients receive usual information

Patients receive usual information before Scheduled Coronarography

usual information

Intervention Type OTHER

usual information for coronarography

patients receive modern information

Patients receive usual information and a information by video before Scheduled Coronarography

modern information

Intervention Type OTHER

information by video for coronarography

usual information

Intervention Type OTHER

usual information for coronarography

Interventions

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modern information

information by video for coronarography

Intervention Type OTHER

usual information

usual information for coronarography

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French Cardiology Society

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status

CHU Jean MINJOZ

Besançon, , France

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Chu Avicennes

Bobigny, , France

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Chu Brest

Brest, , France

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Hôpital Cardiologique Louis Pradel

Bron, , France

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Ch Chartres

Chartres, , France

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Hôpital Gabriel Montpied

Clermont-Ferrand, , France

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Chu Mondor

Crétail, , France

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CHU Dijon

Dijon, , France

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Chu Grenoble

Grenoble, , France

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CH Lagny

Jossigny, , France

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CH MANS

Le Mans, , France

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Chru Lille

Lille, , France

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Chu Marseille

Marseille, , France

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CH

Mâcon, , France

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CH d'ANNECY-GENEVOIS

Metz-Tessy, , France

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Groupe intercommunal Le Raincy Montfermeil

Montfermeil, , France

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CHRU

Montpellier, , France

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CHI André Grégoire

Montreuil, , France

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CHU Nord LAENNEC

Nantes, , France

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Clinique Ambroise Paré

Neuilly-sur-Seine, , France

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Chu Nimes

Nîmes, , France

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Chu Pitie Salpetriere

Paris, , France

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European Georges Pompidou Hospital

Paris, , France

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Bichat

Paris, , France

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Chu Ambroise Paré

Paris, , France

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CHU Saint Antoine

Paris, , France

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Cochin

Paris, , France

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Lariboisière

Paris, , France

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Ch Perpignan

Perpignan, , France

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Hopital Cardiologique Haut Lévèque

Pessac, , France

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CHU Poitiers

Poitiers, , France

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Chu Reims

Reims, , France

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Chu Rennes

Rennes, , France

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CH Yves Le FOLL

Saint-Brieuc, , France

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Centre Cardiologique du Nord

Saint-Denis, , France

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Chu Strasbourg

Strasbourg, , France

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CHU Toulouse Rangueil

Toulouse, , France

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Hôpital Trousseau

Tours, , France

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CHRU Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

References

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Lattuca B, Barber-Chamoux N, Alos B, Sfaxi A, Mulliez A, Miton N, Levasseur T, Servoz C, Derimay F, Hachet O, Motreff P, Metz D, Lairez O, Mewton N, Belle L, Akodad M, Mathivet T, Ecarnot F, Pollet J, Danchin N, Steg PG, Juilliere Y, Bouleti C; INFOCORO investigators. Impact of video on the understanding and satisfaction of patients receiving informed consent before elective inpatient coronary angiography: A randomized trial. Am Heart J. 2018 Jun;200:67-74. doi: 10.1016/j.ahj.2018.03.006. Epub 2018 Mar 12.

Reference Type DERIVED
PMID: 29898851 (View on PubMed)

Other Identifiers

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2014-04

Identifier Type: -

Identifier Source: org_study_id

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