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

Phase 4

Completed

• Conditions: High Risk Hypertensive Patients
• Interventions: Other: Cardiovascular drugs strategies; Behavioral: Compliance; Behavioral: Exercise; Behavioral: Stop Smoking; Behavioral: Diet; Other: Feed Back

• Registration Number: NCT00348855
• Lead Sponsor: Collège National des Généralistes Enseignants

Brief 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

Study Timeline

• Study First Submitted: 2006-07-03
• Study First Submitted QC: 2006-07-05
• Study First Posted: 2006-07-06
• Study Start: 2006-11
• Primary Completion: 2009-09
• Study Completion: 2010-03
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-12
• Last Update Posted: 2011-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1836

Inclusion Criteria

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

Exclusion Criteria

• Secondary prevention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cardiovascular drugs strategies	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.
1	Compliance	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.
1	Exercise	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.
1	Stop Smoking	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.
1	Feed Back	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.
1	Diet	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Service de Pharmacologie Clinique; 🇫🇷 Lyon, France

French National College of GP Teatchers; 🇫🇷 Vincennes, France