Clinical trial NCT00348855: Study to Improve Quality of Care and Patient Health in the Field of Cardiovascular Risk Factors in General Practice
Official title: Effects of a Series of Intensified Prevention Consultations on the Changes in Goals and Risk Factors in Hypertensive Patients at High Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: High Risk Hypertensive Patients
Keywords: High Blood Pressure
High cardiovascular risk
Type 2 diabetes
Reaching goals
Lead sponsor: Collège National des Généralistes Enseignants
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Assistance Publique - Hôpitaux de Paris
name: Laboratoires Takeda
name: Merck Serono International SA
First posted: 2006-07-06
Enrollment: 1836
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Secondary prevention

Primary outcomes:
measure: 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.
timeFrame: At inclusion, year 1 and year 2
Secondary outcomes:
measure: Number of targets reached by the patients
timeFrame: At inclusion, year 1 and year 2
measure: Quality of life measured with SF8
timeFrame: At inclusion, year 1 and year 2
measure: Compliance
timeFrame: At inclusion, year 1 and year 2
measure: Exercise
timeFrame: At inclusion, year 1 and year 2
measure: Diet
timeFrame: At inclusion, year 1 and year 2
measure: Levels of blood pressure, LDL-Cholesterol, tobacco consumption in the whole population plus levels of HbA1c and aspirin use in the TD2 population
timeFrame: inclusion, year 1 and year 2
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Pharmacologie Clinique
city: Vincennes
country: France
facility: French National College of GP Teatchers
Study officials:
affiliation: French National College of GP Teatchers
name: Denis POUCHAIN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: EZUS LYON
name: Michel LIEVRE, MD
role: STUDY_DIRECTOR
affiliation: French National College of GP Teatchers
name: Dominique HUAS, MD
role: STUDY_DIRECTOR
References:
citation: Lebeau JP, Cadwallader JS, Vaillant-Roussel H, Pouchain D, Yaouanc V, Aubin-Auger I, Mercier A, Rusch E, Remmen R, Vermeire E, Hendrickx K. General practitioners' justifications for therapeutic inertia in cardiovascular prevention: an empirically grounded typology. BMJ Open. 2016 May 13;6(5):e010639. doi: 10.1136/bmjopen-2015-010639.
citation: Pouchain D, Lievre M, Huas D, Lebeau JP, Renard V, Bruckert E, Girerd X, Boutitie F; French National College of Teachers in General Practice. Effects of a multifaceted intervention on cardiovascular risk factors in high-risk hypertensive patients: the ESCAPE trial, a pragmatic cluster randomized trial in general practice. Trials. 2013 Oct 1;14:318. doi: 10.1186/1745-6215-14-318.