Evaluation of the Information of the Patient Before a Scheduled Coronarography

Cardiac Disease Clinical Trial

— INFOCORO  

Official title:

Evaluation of the Information of the Patient Before a Scheduled Coronarography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02484144
• Other study ID #: 2014-04
• Status: Completed
• Phase: N/A
• First received: June 24, 2015
• Last updated: October 13, 2016
• Start date: July 2015
• Est. completion date: February 2016

Study information

• Verified date: October 2016
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 821
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Other:
• modern information
information by video for coronarography
• usual information
usual information for coronarography

Locations

Country	Name	City	State
France	CHU Amiens	Amiens
France	CHU Jean MINJOZ	Besançon
France	Chu Avicennes	Bobigny
France	Chu Brest	Brest
France	Hôpital Cardiologique Louis Pradel	Bron
France	Ch Chartres	Chartres
France	Hôpital Gabriel Montpied	Clermont Ferrand
France	Chu Mondor	Crétail
France	CHU Dijon	Dijon
France	Chu Grenoble	Grenoble
France	CH Lagny	Jossigny
France	CH MANS	Le Mans
France	Chru Lille	Lille
France	CH	Macon
France	Chu Marseille	Marseille
France	CH d'ANNECY-GENEVOIS	Metz-tessy
France	Groupe intercommunal Le Raincy Montfermeil	Montfermeil
France	CHRU	Montpellier
France	CHI André Grégoire	Montreuil-sous-bois
France	CHU Nord LAENNEC	Nantes
France	Clinique Ambroise Paré	Neuilly Sur Seine
France	Chu Nimes	Nimes
France	Bichat	Paris
France	Chu Ambroise Paré	Paris
France	Chu Pitie Salpetriere	Paris
France	CHU Saint Antoine	Paris
France	Cochin	Paris
France	European Georges Pompidou Hospital	Paris
France	Lariboisière	Paris
France	Ch Perpignan	Perpignan
France	Hopital Cardiologique Haut Lévèque	Pessac
France	CHU Poitiers	Poitiers
France	Chu Reims	Reims
France	Chu Rennes	Rennes
France	CH Yves Le FOLL	Saint Brieuc
France	Centre Cardiologique du Nord	Saint-Denis
France	Chu Strasbourg	Strasbourg
France	CHU Toulouse Rangueil	Toulouse
France	Hôpital Trousseau	Tours
France	CHRU Nancy	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of the quality of the information of the patients	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	No