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临床试验/NCT03923790
NCT03923790已完成不适用

Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2019年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
2
主要终点
Daytime Ambulatory Systolic Blood Pressure

研究概览

简要总结

The purpose of this pilot trial is to compare post-stroke care blood pressure (BP) treatment using an interdisciplinary telehealth model [called the Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction] to usual care in stroke patients at risk for uncontrolled BP. The intervention will address general and stroke-related factors associated with racial disparities in BP control. We will assess feasibility of implementation of the trial and will use the measures and outcomes assessed in the pilot to examine knowledge gaps.

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
Single (Outcomes Assessor)

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

  • Ischemic and hemorrhagic stroke patients
  • Presence of at least one of the following high risk criteria: uninsured, Medicaid payer status, small vessel ischemic stroke, hypertensive ICH)
  • Age ≥ 18; presence of hypertension (by clinical history or hospital BP ≥140/90 on two occasions)
  • Plan to discharge home after stroke
  • Ability to provide consent (patient or caregiver)
  • Ability to communicate in English

排除标准

  • modified Rankin scale > 4 at the time of enrollment (severe disability)
  • life expectancy < 1 year or terminal illness,
  • eGFR < 30 at time of discharge
  • pregnancy
  • symptomatic flow limiting carotid stenosis without plan for intervention
  • urine toxicology positive for cocaine or methamphetamine or recent use
  • long-term BP goal ≥ 130/80 mmHg according to clinical team

结局指标

主要结局

Daytime Ambulatory Systolic Blood Pressure

时间窗: 6 months after enrollment

Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).

次要结局

  • Nighttime Diastolic Blood Pressure(6 months)
  • Body Mass Index(BMI)(6 months)
  • Night Time Ambulatory Systolic Blood Pressure(6 months)
  • Daytime Ambulatory Diastolic Blood Pressure(6 months)
  • Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death)(6 months)
  • Number of Participants With Acute Healthcare Utilization(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anjail Z Sharrief

Assistant Professor

The University of Texas Health Science Center, Houston

研究点 (2)

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