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

Collège National des Généralistes Enseignants

Status and phase: Completed; Phase 4

Conditions: High Risk Hypertensive Patients

Treatments: Other: Feed Back; Behavioral: Compliance; Other: Cardiovascular drugs strategies; Behavioral: Exercise; Behavioral: Diet; Behavioral: Stop Smoking

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00348855

CNGE20060702

Details and patient eligibility

About

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.

Full description

Cluster randomised pragmatic controlled trial in general practice

Enrollment: 1,836 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treated High blood Pressure patients with at least two other cardiovascular risks

Exclusion criteria

• Secondary prevention

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,836 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Behavioral: Diet

Behavioral: Exercise

Behavioral: Compliance

Other: Feed Back

Other: Cardiovascular drugs strategies

Behavioral: Stop Smoking

2

No Intervention group