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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- High Blood Pressure in 12 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Therapeutic education HTA Vasc
125 subjects who participate in the therapeutic education program
干预措施: Therapeutic education HTA Vasc (Other)
Control group
125 subjects who don't participate in the therapeutic education program
结局指标
主要结局
High Blood Pressure in 12 months
时间窗: 12 months
Percentage of patients with a blood pressure of 140/90 mmHg or less in 12 months
次要结局
- High Blood pressure at 24 months(24 months)