Study to Improve Quality of Care and Patient Health in the Field of Cardiovascular Risk Factors in General Practice
Condition: High Risk Hypertensive Patients
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Cluster randomised pragmatic controlled trial in general practice
    

Intervention name(s): Cardiovascular drugs strategies; Compliance; Exercise; Stop Smoking; Diet; Feed Back
Intervention type(s): Other; Behavioral; Behavioral; Behavioral; Behavioral; Other
Intervention description(s): Implementation of drug strategies according to guidelines to try to reach goals proposed in these guidelines.; Discussion about compliance and questionnaire to assess compliance at inclusion, Year 1 and Year 2.; Discussion with the patient on necessity to have regular exercise. Assessment of exercise by questionnaire at inclusion, year 1 and year 2.; Minimal intervention; 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.; Feed back on results in the intervention group at baseline, Year 1 ans Year 2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: High Blood Pressure; High cardiovascular risk; Type 2 diabetes; Reaching goals