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

Study Overview
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Brief Summary
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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
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Cluster randomised pragmatic controlled trial in general practice

Official Title
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Effects of a Series of Intensified Prevention Consultations on the Changes in Goals and Risk Factors in Hypertensive Patients at High Cardiovascular Risk

Conditions
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High Risk Hypertensive Patients

Intervention / Treatment
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* Other: Cardiovascular drugs strategies
* Behavioral: Compliance
* Behavioral: Exercise
* Behavioral: Stop Smoking
* Behavioral: Diet
* Other: Feed Back


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treated High blood Pressure patients with at least two other cardiovascular risks Exclusion Criteria: Secondary prevention

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intervention with one day training, electronic device to measure bood pressure, leaflet with goals and drug strategies according to guidelines, six specific cardiovascular consultations during two years, feed back on results of the intervention group at inclusion, year 1 and year 2. Specific consultations will be focused on goals to be reach, compliance, exercise and diet. | Other: Cardiovascular drugs strategies<br>* Implementation of drug strategies according to guidelines to try to reach goals proposed in these guidelines.<br>Behavioral: Compliance<br>* Discussion about compliance and questionnaire to assess compliance at inclusion, Year 1 and Year 2.<br>Behavioral: Exercise<br>* Discussion with the patient on necessity to have regular exercise. Assessment of exercise by questionnaire at inclusion, year 1 and year 2.<br>Behavioral: Stop Smoking<br>* Minimal intervention<br>Behavioral: Diet<br>* 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.<br>Other: Feed Back<br>* Feed back on results in the intervention group at baseline, Year 1 ans Year 2.<br>|
| No Intervention: 2<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who reach all the therapeutic goals 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 T2D. |  | At inclusion, year 1 and year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of targets reached by the patients |  | At inclusion, year 1 and year 2 | 
| Quality of life measured with SF8 |  | At inclusion, year 1 and year 2 | 
| Compliance |  | At inclusion, year 1 and year 2 | 
| Exercise |  | At inclusion, year 1 and year 2 | 
| Diet |  | At inclusion, year 1 and year 2 | 
| Levels of blood pressure, LDL-Cholesterol, tobacco consumption in the whole population plus levels of HbA1c and aspirin use in the TD2 population |  | inclusion, year 1 and year 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Blood Pressure, High cardiovascular risk, Type 2 diabetes, Reaching goals