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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01781416
First received: January 30, 2013
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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
Cardiovascular Risk

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Level of Concordance Between Patients Perception and Physicians Evaluation of Cardiovascular Risk

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Cardiovascular risk perceived by patients (before reading the Medical Information Leaflet) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Cardiovascular risk assessed by physicians [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular risks perceived by patients before and after reading the Medical Information Leaflet [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Actual cardiovascular risk calculated using SCORE [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Characteristics of patients whose self-evaluation of their CVR is concordant with their actual CVR [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Characteristics of patients whose self-evaluation of their CVR is discordant with their actual CVR [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Risk factors considered by patients in self-assessing their CVR [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 799
Study Start Date: November 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01781416     History of Changes
Other Study ID Numbers: NIS-CFR-XXX-2012/1
Study First Received: January 30, 2013
Last Updated: May 19, 2014
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)

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

ClinicalTrials.gov processed this record on November 20, 2014