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

Cardiovascular Risk Clinical Trial

— PERCEPTION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781416
• Other study ID #: NIS-CFR-XXX-2012/1
• Status: Completed
• Phase: N/A
• First received: January 30, 2013
• Last updated: May 19, 2014
• Start date: November 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Committee on Treatment information for Health and Life Sciences : CCTIRS (Comite Consultatif sur le Traitement de l'Information en matiere de Recherche dans le domaine de la Sante)France: National Data Privacy Authority : CNIL (Commission Nationale de l'Informatique et des Libertes)France: National Doctors Governing Body : CNOM (Conseil National de l'Ordre des Medecins)
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 799
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Risk

Locations

Country	Name	City	State
France	Research Site	PARIS Cedex 15

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular risk perceived by patients (before reading the Medical Information Leaflet)		Baseline	No
Primary	Cardiovascular risk assessed by physicians		Baseline	No
Secondary	Cardiovascular risks perceived by patients before and after reading the Medical Information Leaflet		Baseline	No
Secondary	Actual cardiovascular risk calculated using SCORE		Baseline	No
Secondary	Characteristics of patients whose self-evaluation of their CVR is concordant with their actual CVR		Baseline	No
Secondary	Characteristics of patients whose self-evaluation of their CVR is discordant with their actual CVR		Baseline	No
Secondary	Risk factors considered by patients in self-assessing their CVR		Baseline	No