Study to Improve Quality of Care and Patient Health in the Field of Cardiovascular Risk Factors in General Practice

Summary

Observational studies performed in France and abroad in hypertensive patients at high cardiovascular risk have shown a wide gap between the therapeutic targets reached in ambulatory patients and those set by guidelines. In primary prevention, in hypertensive patients at high cardiovascular risk (+ at least 2 risk factors), the gap is secondary to 1) the ignorance of the validated therapeutic targets and strategies, 2) the absence of global cardiovascular risk management, 3) the usual ambulatory medical practice, which is not adapted to a global cardiovascular prevention approach.

Objectives Principal. To demonstrate that a series of 5 specific prevention consultations over 2 years allows a greater number of hypertensive patients at high cardiovascular risk to reach the goals set by guidelines with no deterioration of their quality of life compared with no particular intervention.

Method Pragmatic, cluster-randomised controlled trial. At least 1904 high cardiovascular risk hypertensive patients will be included and followed up during two years by 268 teaching general practitioners from 23 regional teaching colleges. The regional teaching colleges will be randomised to avoid a contamination bias. The study will be coordinated by local coordinators at the college level.

Intervention In the intervention group, the investigators will have training, information, and feed back regarding the management of high risk hypertensive patients. The training will concern the targets to be reached, therapeutic strategies recommended by the AFSSAPS/HAS, and scientific data. The investigators will have an easy guide that can be used during consultations, and will be informed about tobacco withdrawal programs and education for improving diet, exercise and compliance.

In the control group, investigators will care for their patients as usual. End points Main: number of patients who reach all the therapeutic targets defined by the guidelines in the total study population, in the sub-group of patients with hypertension, but free of type-2 diabetes (T2D), and in the sub-group with hypertension and DT2.

Secondary: number of targets reached by the patients, changes in level of blood pressure, LDL-cholesterol, HbA1c, tobacco consumption, and use of aspirin if needed in the total population and its two subgroups, estimated cardiovascular risk, quality of life.

Conditions

• High Risk Hypertensive Patients

Interventions

OTHER

Cardiovascular drugs strategies

Implementation of drug strategies according to guidelines to try to reach goals proposed in these guidelines.

BEHAVIORAL

Compliance

Discussion about compliance and questionnaire to assess compliance at inclusion, Year 1 and Year 2.

BEHAVIORAL

Exercise

Discussion with the patient on necessity to have regular exercise. Assessment of exercise by questionnaire at inclusion, year 1 and year 2.

BEHAVIORAL

Stop Smoking

Minimal intervention

BEHAVIORAL

Diet

Discussion with the patient on his (her) alimentation during each of the six consultations and assessment of daily diet at inclusion, year 1 and year 2.

OTHER

Feed Back

Feed back on results in the intervention group at baseline, Year 1 ans Year 2.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• Assistance Publique - Hôpitaux de Paris

  collaborator OTHER

• Laboratoires Takeda

  collaborator INDUSTRY

• Merck Serono International SA

  collaborator INDUSTRY

• Collège National des Généralistes Enseignants

  lead OTHER

Principal Investigators

• Denis POUCHAIN, MD · French National College of GP Teatchers

• Michel LIEVRE, MD · EZUS LYON

• Dominique HUAS, MD · French National College of GP Teatchers

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-11-30

Primary Completion

2009-09-30

Completion

2010-03-31

Countries

• France

Study Locations