PERCEPTION: Level of Concordance Between Patients Perception and Physicians Evaluation of Cardiovascular Risk

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01781416

Collaborator

(none)

799

Enrollment

Location

Duration (Months)

161.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a national, non interventional, prospective study performed in the general practice setting.

The study has been designed :

to assess the level of concordance between patients' cardiovascular risk perception and the cardiovascular risk evaluated by the physicians,
and to evaluate the impact of patients' exposure to a medical information leaflet on patients' cardiovascular risk perception.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Risk

Detailed Description

LEVEL OF CONCORDANCE BETWEEN PATIENTS PERCEPTION AND PHYSICIANS EVALUATION OF CARDIOVASCULAR RISK

Study Design

Study Type:

Observational

Actual Enrollment :

799 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Level of Concordance Between Patients Perception and Physicians Evaluation of Cardiovascular Risk

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
1

Outcome Measures

Primary Outcome Measures

Cardiovascular risk perceived by patients (before reading the Medical Information Leaflet) [Baseline]
Cardiovascular risk assessed by physicians [Baseline]

Secondary Outcome Measures

Cardiovascular risks perceived by patients before and after reading the Medical Information Leaflet [Baseline]
Actual cardiovascular risk calculated using SCORE [Baseline]
Characteristics of patients whose self-evaluation of their CVR is concordant with their actual CVR [Baseline]
Characteristics of patients whose self-evaluation of their CVR is discordant with their actual CVR [Baseline]
Risk factors considered by patients in self-assessing their CVR [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Currently in primary prevention for a cardiovascular event (patient with no known history of acute cardiovascular or cerebrovascular event)
Usually treated by the GP
Having signed the information and consent form

Exclusion Criteria:

Patient with a pathologic vascular ultrasound exam (atheromatous plaque or stenosis)
Patient unable to read and complete the study documentation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	PARIS Cedex 15		France

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair: Atul PATHAK, Professor, Service de Pharmacologie Clinique - Unite INSERM U 1048 - Faculte de Medecine - 37 Allees Jules Guesde -31073 Toulouse- FRANCE
Study Chair: Nicolas DANCHIN, Professor, Unite des Maladies Coronaires - Hopital Europeen Georges Pompidou - 20 Rue Leblanc - 75015 Paris - FRANCE