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

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ClinicalTrials.gov Identifier: NCT01781416
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):

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
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 : November 2013
Primary Completion Date : April 2014
Study Completion Date : April 2014
Groups and Cohorts

Group/Cohort
1


Outcome Measures

Primary Outcome Measures :
  1. Cardiovascular risk perceived by patients (before reading the Medical Information Leaflet) [ Time Frame: Baseline ]
  2. Cardiovascular risk assessed by physicians [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Cardiovascular risks perceived by patients before and after reading the Medical Information Leaflet [ Time Frame: Baseline ]
  2. Actual cardiovascular risk calculated using SCORE [ Time Frame: Baseline ]
  3. Characteristics of patients whose self-evaluation of their CVR is concordant with their actual CVR [ Time Frame: Baseline ]
  4. Characteristics of patients whose self-evaluation of their CVR is discordant with their actual CVR [ Time Frame: Baseline ]
  5. Risk factors considered by patients in self-assessing their CVR [ Time Frame: Baseline ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All adults aged 50 and over who :

  • are currently in primary prevention for a cardiovascular event,
  • are usually treated by the general practitioner,
  • and have a medical visit during the study period.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781416


Locations
France
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
More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01781416     History of Changes
Other Study ID Numbers: NIS-CFR-XXX-2012/1
First Posted: February 1, 2013    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014

Keywords provided by AstraZeneca:
cardiovascular risk
SCORE
cardiovascular primary prevention
risk factors