Effects of a Series of Intensified Prevention Consultations on the Changes in Goals and Risk Factors in Hypertensive Patients at High Cardiovascular Risk
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,836
- 试验地点
- 4
- 主要终点
- Number of patients who reach all the therapeutic goals defined by the guidelines in the total study population, in the sub-group of patients with hypertension, but free of type-2 diabetes (T2D), and in the sub-group with hypertension and T2D.
研究概览
简要总结
Observational studies performed in France and abroad in hypertensive patients at high cardiovascular risk have shown a wide gap between the therapeutic targets reached in ambulatory patients and those set by guidelines. In primary prevention, in hypertensive patients at high cardiovascular risk (+ at least 2 risk factors), the gap is secondary to 1) the ignorance of the validated therapeutic targets and strategies, 2) the absence of global cardiovascular risk management, 3) the usual ambulatory medical practice, which is not adapted to a global cardiovascular prevention approach.
Objectives Principal. To demonstrate that a series of 5 specific prevention consultations over 2 years allows a greater number of hypertensive patients at high cardiovascular risk to reach the goals set by guidelines with no deterioration of their quality of life compared with no particular intervention.
Method Pragmatic, cluster-randomised controlled trial. At least 1904 high cardiovascular risk hypertensive patients will be included and followed up during two years by 268 teaching general practitioners from 23 regional teaching colleges. The regional teaching colleges will be randomised to avoid a contamination bias. The study will be coordinated by local coordinators at the college level.
Intervention In the intervention group, the investigators will have training, information, and feed back regarding the management of high risk hypertensive patients. The training will concern the targets to be reached, therapeutic strategies recommended by the AFSSAPS/HAS, and scientific data. The investigators will have an easy guide that can be used during consultations, and will be informed about tobacco withdrawal programs and education for improving diet, exercise and compliance.
In the control group, investigators will care for their patients as usual. End points Main: number of patients who reach all the therapeutic targets defined by the guidelines in the total study population, in the sub-group of patients with hypertension, but free of type-2 diabetes (T2D), and in the sub-group with hypertension and DT2.
Secondary: number of targets reached by the patients, changes in level of blood pressure, LDL-cholesterol, HbA1c, tobacco consumption, and use of aspirin if needed in the total population and its two subgroups, estimated cardiovascular risk, quality of life.
详细描述
Cluster randomised pragmatic controlled trial in general practice
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
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated High blood Pressure patients with at least two other cardiovascular risks
排除标准
- •Secondary prevention
结局指标
主要结局
Number of patients who reach all the therapeutic goals defined by the guidelines in the total study population, in the sub-group of patients with hypertension, but free of type-2 diabetes (T2D), and in the sub-group with hypertension and T2D.
时间窗: At inclusion, year 1 and year 2
次要结局
- Number of targets reached by the patients(At inclusion, year 1 and year 2)
- Quality of life measured with SF8(At inclusion, year 1 and year 2)
- Compliance(At inclusion, year 1 and year 2)
- Exercise(At inclusion, year 1 and year 2)
- Diet(At inclusion, year 1 and year 2)
- Levels of blood pressure, LDL-Cholesterol, tobacco consumption in the whole population plus levels of HbA1c and aspirin use in the TD2 population(inclusion, year 1 and year 2)
研究者
Denis Pouchain
MD
Collège National des Généralistes Enseignants