Efficacy of a Dedicated Therapeutic Education Program in Patients at High Cardiovascular Risk

Not Applicable

Completed

• Conditions: High Blood Pressure
• Interventions: Other: Therapeutic education HTA Vasc

• Registration Number: NCT01622400
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-19
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic education HTA Vasc	Therapeutic education HTA Vasc	125 subjects who participate in the therapeutic education program

Primary Outcome Measures

Name	Time	Method
High Blood Pressure in 12 months	12 months	Percentage of patients with a blood pressure of 140/90 mmHg or less in 12 months

Secondary Outcome Measures

Name	Time	Method
High Blood pressure at 24 months	24 months	Percentage of patients with a blood pressure of 140/90 mmHg or less in 24 months

Trial Locations

Locations (2)

General Practice Office; 🇫🇷 Arras, France

General practice office; 🇫🇷 Lille, France