Efficacy of a Dedicated Therapeutic Education Program in Patients at High Cardiovascular Risk
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- High Blood Pressure in 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]Percentage of patients with a blood pressure of 130/80 mmHg or less in 12 months
- High Blood pressure at 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]Percentage of patients with a blood pressure of 130/80 mmHg or less in 24 months
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Therapeutic education HTA Vasc
125 subjects who participate in the therapeutic education program
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.
Other Name: Program proposed by the association HTA Vasc
No Intervention: Control group
125 subjects who don't participate in the therapeutic education program
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622400
|General Practice Office|
|General practice office|
|Principal Investigator:||FAYOLLE PF Patrick, GP||Arras Principal Investigator|
|Principal Investigator:||GOUDJI GG Gustave, GP||Lille Principal Investigator|