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临床试验/NCT04226157
NCT04226157Unknown不适用

Home Blood Pressure Self-Management in Hypertensive Stroke Survivors: a Pilot Study

MedStar Georgetown University Hospital2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年2月21日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
32
试验地点
2
主要终点
Feasibility of blood pressure self management in stroke survivors

研究概览

简要总结

The purpose of this pilot study is to assess the feasibility of implementing a home blood pressure self-management program in a population of recent stroke survivors in the Washington, D.C. area. The investigators hypothesize that hypertensive stroke survivors in the Washington, DC area who participate in the Home Blood Pressure Monitoring program will have a greater reduction in mean systolic blood pressure (SBP) from baseline to 3 months, as measured by automated office blood pressure (AOBP), as compared to usual care.

详细描述

The purpose of this trial is to determine if a home blood pressure self-management (HBPS) program, including home monitoring and medication adjustments, is practical to use in recent stroke survivors and whether or not it is associated with lowering blood pressure after 3 months. Data from this trial may be used to do more research and may be used by doctors when seeing patients.This research is being done because high blood pressure, also called hypertension, is the leading risk factor for stroke. Lowering blood pressure (BP) has been shown to lower the risk of future strokes. The majority of stroke survivors continue to have uncontrolled BP. Currently, blood pressure (BP) is most often measured in the doctor's office. However, those single BP measurements are not the best picture of blood pressure over time and can be influenced by the stress of being in a doctor's office, known as the "white coat effect". This is why measuring BP at home may paint a more accurate picture of a patient's true long-term BP. Home blood pressure monitoring (HBPM) is recommended in the recently updated national hypertension guidelines. Home BP monitoring plus guided BP medication self-adjustments is associated with lower BP in patients with high blood pressure. The investigators believe that a HBPS program, including medication self-adjustment and home monitoring, may help to reduce blood pressure in patients with hypertension within 3 months.

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

入选标准

  • Acute ischemic stroke in the past 180 days of screening
  • Age >/= 18 years old
  • Automated Office Blood Pressure ≥135 systolic or ≥85 diastolic at time of screening
  • Stage 2 hypertension (as defined by >140 mmHg SBP and or >90 mmHg DBP on 2 occasions or history of hypertension prior to stroke or currently taking antihypertensive medications)
  • Able to live independently (as defined by modified Rankin scale score of 0-2)

排除标准

  • CKD stage IV or greater (GFR < 30)
  • Inability to check BP in either arm (e.g. amputation, lymphedema)
  • Pregnancy
  • High-grade intracranial or extracranial stenosis requiring a higher BP goal
  • Unable to provide informed consent for themselves in English or Spanish
  • Life expectancy less than 12 months

结局指标

主要结局

Feasibility of blood pressure self management in stroke survivors

时间窗: Three Months

At least 75 percent of HBPS participants will successfully complete the monitoring and self-titration intervention.

次要结局

  • Systolic Blood Pressure Difference(three months)

研究者

发起方
MedStar Georgetown University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Mary Carter Denny

Assistant Professor of Neurology

MedStar Georgetown University Hospital

研究点 (2)

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