Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A00333-38 | Other Identifier | ID-RCB number, ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Association HTA Vasc | OTHER |
| CRESGE (Centre de Recherches Economiques Sociologiques et de Gestion) | UNKNOWN |
| CERIM (Centre d'Etudes et de Recherche en Informatique Médicale), P. Devos | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic education HTA Vasc | Experimental | 125 subjects who participate in the therapeutic education program |
|
| Control group | No Intervention | 125 subjects who don't participate in the therapeutic education program |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic education HTA Vasc | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| High Blood Pressure in 12 months | Percentage of patients with a blood pressure of 140/90 mmHg or less in 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| High Blood pressure at 24 months | Percentage of patients with a blood pressure of 140/90 mmHg or less in 24 months | 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| FAYOLLE PF Patrick, GP | Arras Principal Investigator | Principal Investigator |
| GOUDJI GG Gustave, GP | Lille Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Practice Office | Arras | France | ||||
| General practice office |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Lille |
| France |