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

NCT01781416 | Completed

• 1 other identifier: NIS-CFR-XXX-2012/1
• Study Type: observational
• Target: 799
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk

Keywords

cardiovascular risk; SCORE; cardiovascular primary prevention; risk factors

Outcome Measures

Primary Outcomes (2)

• Cardiovascular risk perceived by patients (before reading the Medical Information Leaflet)

  Baseline

• Cardiovascular risk assessed by physicians

  Baseline

Secondary Outcomes (5)

• 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

Study Arms (1)

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Paris, France

Location

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: February 1, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

FR (1)