Clinical trial NCT02484144: Evaluation of the Information of the Patient Before a Scheduled Coronarography
Official title: Evaluation of the Information of the Patient Before a Scheduled Coronarography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Keywords: information
coronarography
understanding
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 821
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with scheduled coronarography

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement of the quality of the information of the patients
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Besançon
country: France
facility: CHU Jean MINJOZ
city: Bobigny
country: France
facility: Chu Avicennes
city: Brest
country: France
facility: Chu Brest
city: Bron
country: France
facility: Hôpital Cardiologique Louis Pradel
city: Chartres
country: France
facility: Ch Chartres
city: Clermont Ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Crétail
country: France
facility: Chu Mondor
city: Dijon
country: France
facility: CHU Dijon
city: Grenoble
country: France
facility: Chu Grenoble
city: Jossigny
country: France
facility: CH Lagny
city: Le Mans
country: France
facility: CH MANS
city: Lille
country: France
facility: Chru Lille
city: Macon
country: France
facility: CH
city: Marseille
country: France
facility: Chu Marseille
city: Metz-tessy
country: France
facility: CH d'ANNECY-GENEVOIS
city: Montfermeil
country: France
facility: Groupe intercommunal Le Raincy Montfermeil
city: Montpellier
country: France
facility: CHRU
city: Montreuil-sous-bois
country: France
facility: CHI André Grégoire
city: Nantes
country: France
facility: CHU Nord LAENNEC
city: Neuilly Sur Seine
country: France
facility: Clinique Ambroise Paré
city: Nimes
country: France
facility: Chu Nimes
city: Paris
country: France
facility: Chu Pitie Salpetriere
city: Paris
country: France
facility: European Georges Pompidou Hospital
city: Paris
country: France
facility: Bichat
city: Paris
country: France
facility: Chu Ambroise Paré
city: Paris
country: France
facility: CHU Saint Antoine
city: Paris
country: France
facility: Cochin
city: Paris
country: France
facility: Lariboisière
city: Perpignan
country: France
facility: Ch Perpignan
city: Pessac
country: France
facility: Hopital Cardiologique Haut Lévèque
city: Poitiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: Chu Reims
city: Rennes
country: France
facility: Chu Rennes
city: Saint Brieuc
country: France
facility: CH Yves Le FOLL
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
city: Strasbourg
country: France
facility: Chu Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse Rangueil
city: Tours
country: France
facility: Hôpital Trousseau
city: Vandoeuvre Les Nancy
country: France
facility: CHRU Nancy
Study officials:
References:
citation: 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.