A Randomized Controlled Trial of the Effects of Home Blood Pressure Monitoring on Blood Pressure Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 597
- 试验地点
- 2
- 主要终点
- Achieving BP target at end of study
研究概览
简要总结
Hypertension is a common problem in Canada with a prevalence of about 15%. The goal of hypertension therapy should be to maximize blood pressure control. Home blood pressure monitoring (HBPM) devices are available and many patients are using them. The role that self-monitoring of blood pressure can play in optimizing blood pressure control is unclear. We hope to clarify the role of home blood pressure monitoring in the treatment of hypertension and explore how it may affect patient and physician behaviours related to blood pressure management. This study will compare a group of hypertensive patients who use HBPM with those who do not use these devices. The intervention (HBPM) group will measure their blood pressure at home a minimum of once weekly and will report these measurements to their family doctor at each visit. The control group will receive usual care as delivered by their family doctor. Outcomes of blood pressure control will be measured over a 12 month period. Outcomes will be determined primarily by 24 hour ambulatory blood pressure monitoring and by reviewing data in patient's charts located in family physicians office. Fifty family physicians from the Kingston area have agreed to participate.
详细描述
The objective of this study is to measure the effect of home (self) blood pressure monitoring on control of hypertension in a primary care setting.
This research is important for several reasons:
i) Lack of control of hypertension is common and is associated with morbidity and mortality.
ii) The costs of managing hypertensions are high, not only because of the prevalence of hypertension, but also because maintenance of control must exist over many years for most patients.
iii) Home blood pressure monitoring is increasingly being used by patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •adults age 18 years and older with essential hypertension.
- •who are treated with medication to lower their blood pressure.
- •whose mean daytime blood pressure at enrolment is 135/85 mm Hg or greater.
- •and who are not currently using HBPM.
排除标准
- •a diagnosis of secondary hypertension.
- •pregnancy.
- •hypertension management primarily by a consultant.
- •a disability that precludes use of a home blood pressure monitor.
- •enrolled in another hypertension trial
- •white coat hypertension
结局指标
主要结局
Achieving BP target at end of study
时间窗: 6mt and 1yr
The mean nighttime blood pressures on ABPM.
时间窗: 6mth and 1yr
次要结局
- the number of visits for hypertension.(6mth & 1yr)
- compliance with hypertensive medication use(6month & 1yr)
- frequency of lifestyle counseling by physician(6month & 1yr)
- Quality of Life as measured by SF-36.(6month & 1yr)
- compliance with the intervention(6month & 1yr)
- patient lifestyle changes.(6mth and 1yr)
- intensity of treatment(6month & 1yr)
研究者
Dr. Richard Birtwhistle
Principal Investigator
Queen's University