NCT01622400

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High Blood Pressure

Interventions

Type	Name	Description
OTHER	Therapeutic education HTA Vasc	The intervention program takes place in 3 phases. First, the education team realizes an individual educational diagnosis to define the objectives of the intervention according to each patient's needs. Secondly, patients assist to 3 to 5 group sessions lasting 2 hours with a dedicated nurse focusing on medical therapy explanation and blood pressure self measurement education - and with a dedicated nutritionist focusing on stress management and nutrition program. Patients can also have individual consultations with the dedicated nutritionist. Finally, an individual assessment permits to evaluate the benefits of the program for each patient and to define new objectives.

Timeline

• Start date: 2011-09-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2012-06-19
• Last updated: 2018-06-20

Locations

2 sites across 1 country: France