Clinical trial NCT01622400: Efficacy of a Dedicated Therapeutic Education Program in Patients at High Cardiovascular Risk
Official title: Randomized Prospective Trial Evaluating the Efficacy of a Dedicated Therapeutic Education Program on the Blood Pressure and Other Cardiovascular Risk Factors Control in General Practice Patients at High Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Blood Pressure
Keywords: Cardiovascular risk, Therapeutic education, General practice
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Association HTA Vasc
name: CRESGE (Centre de Recherches Economiques Sociologiques et de Gestion)
name: CERIM (Centre d'Etudes et de Recherche en Informatique Médicale), P. Devos
First posted: 2012-06-19
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A dedicated therapeutic education program is an essential tool in the management of hypertension as well as in the control of other cardiovascular risk factors. The purpose of this study is therefore to evaluate the effect of such a therapeutic education program in general practice patients at high cardiovascular risk.

Detailed description: Current guidelines for the prevention of cardiovascular disease recognize the major interest of an optimal control of all cardiovascular risk factors. It includes high blood pressure reduction, dietetic measures (weight loss - control of dyslipidemia and diabetes - regular physical activity), smoking cessation, stress management, ... In that way, some authors suggest that it is essential for patients at high risk to have knowledge about their own pathology, medication, and to better understand the real benefit of specific lifestyle behaviors and the importance of blood pressure and glycaemia surveillance ... The aim of this randomized controlled trial is to evaluate the efficacy of a dedicated therapeutic education program to control blood pressure and other cardiovascular risk factors in general practice patients at high cardiovascular risk.

250 patients are being enrolled. All patients will receive standard care but only 125 patients (randomized 1 to 1) will receive a structured therapeutic education program.

Eligibility criteria: Inclusion Criteria:

* Man or woman of more than 18 years with a health insurance policy
* General practice patients who are agree to participate of the program of patient's therapeutic education in Lille (59) or Arras (62)
* Written informed consent must be obtained prior to performing any study-specific procedures
* Patient at high cardiovascular risk (Patient with a high blood pressure and 3 cardiovascular risk factors and/or Patient with cardiovascular disease)

Exclusion Criteria:

* Patient unwilling to take part to the therapeutic education program or to the study
* Patient not suitable to participate in the therapeutic education program
* Patient with dementia
* Anticipated survival (due to comorbidities) of less than one year from baseline
* Patient with current addiction or current alcohol / drug abuse
* Patient with known plans to move to another area of the country
* Unable to obtain written informed consent
* Patient who are pregnant or lactating
* Person without liberty by administrative or judiciary decision

Primary outcomes:
measure: High Blood Pressure in 12 months
timeFrame: 12 months
Secondary outcomes:
measure: High Blood pressure at 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Arras
country: France
facility: General Practice Office
city: Lille
country: France
facility: General practice office
Study officials:
affiliation: Arras Principal Investigator
name: FAYOLLE PF Patrick, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Lille Principal Investigator
name: GOUDJI GG Gustave, GP
role: PRINCIPAL_INVESTIGATOR
References: