Efficacy of Home Blood Pressure Monitoring to Improve Blood Pressure Control: a Randomized Controlled Trial With Ambulatory Blood Pressure Measurement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Delta values for 24h ABPM between baseline and final ABPM measurements
研究概览
简要总结
High blood pressure is the main risk factor for cardiovascular disease worldwide,but its control rate is unsatisfactory. Home Blood Pressure Monitoring (HBPM) with automatic oscillometric devices and pharmaceutical care have been proposed as interventions to increase therapeutic compliance and to guide treatment decisions.
The purpose of this study is to evaluate the effect of HBPM and of pharmaceutical care in blood pressure control measured through 24h ambulatory blood pressure monitoring (ABPM).
详细描述
Home Blood Pressure Monitoring (HBPM) and Pharmaceutical care have been proposed to improve therapeutic compliance and to guide treatment decisions, but their effects on BP control are still under debate.
This is a factorial randomized controlled trial including adult hypertensive patients under drug treatment but with office BP and 24h ABPM uncontrolled. Participants will be allocated to one of four groups: HBPM; HBPM and Pharmaceutical care; Pharmaceutical care; or control. All participants will receive usual care for high blood pressure. Participants will be followed for 60 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Office BP ≥140/90 mm Hg
- •24h ABPM hypertension BP ≥130/80 mm Hg
- •using at least one antihypertensive drug
排除标准
- •BP ≥ 180 / 110 mmHg)
- •major cardiovascular events in the last six months
- •acute or chronic diseases limiting the capacity to understand and to participate in the trial
- •masked hypertension
- •white-coat hypertension
- •secondary hypertension
- •pregnancy
- •breastfeeding
- •concurrent participation in another trial
结局指标
主要结局
Delta values for 24h ABPM between baseline and final ABPM measurements
时间窗: 60 days
次要结局
- Hypertension control(60 days)
- Average of systolic and diastolic blood pressure at the end of the study.(60 days)