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临床试验/NCT03862742
NCT03862742撤回不适用

Role of Wrist Based Blood Pressure Monitoring in Clinical Practice

Scripps Translational Science Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
100
试验地点
1
主要终点
Blood pressure

研究概览

简要总结

This is a pilot clinical study to test the overarching hypothesis that frequent and longitudinal blood pressure monitoring with FDA approved consumer wrist based device during the patient transition from inpatient to home to the first clinic visit will elicit valuable BP data that can assist in physician treatment of hypertension

详细描述

Wrist based health devices, often with mobile connectivity, that continuously or near continuously track heart rate, blood pressure, temperature, activity and sleep are growing in everyday popularity and beginning to enter the sphere of clinical relevance. However, their accuracy and utility for clinical use is largely unstudied. As these consumer devices, some of which are FDA approved, become more commonplace, it is paramount to understand their function, know their limitations, and be able to interpret results appropriately before incorporating them into our clinical practice. The AHA/ACC 2017 guideline makes a 1A recommendation for clinical use of out of office BP measurements(1). This recommendation is based on evidence that out of office BP and frequent and longitudinal BP measurements are important in predicting cardiovascular risk and monitoring treatment efficacy(2-5). This trend towards consumer driven digital health monitoring and the new AHA/ACC guideline are essentially advancing a consumer based precision medicine strategy for diagnosis and monitoring of hypertension. As this becomes commonplace in our patient population, we need rigorous clinical study of wrist base BP monitoring to better understand its role patient care.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • ≥18 years of age
  • Own an iOS or Android device

排除标准

  • Inability to give informed consent
  • <18 years of age
  • Inability to understand written English language
  • Hypertensive urgency or emergency as an admission diagnosis

结局指标

主要结局

Blood pressure

时间窗: Pts will monitor BP during the transition from inpatient to home to the first clinic visit. BP measurements will be performed several times during the day and several times at night. The estimated time frame when data will be collected is 24 to 48 hours

blood pressure measured by the wrist watch like blood pressure device

次要结局

  • Survey of healthcare providers(A survey to measure how easy it is to use the device will be obtained at the completion of data collection. The estimated timeframe when the survey will be completed is 24 to 48 hours.)
  • Survey of patients(A survey to measure how easy it is to use the device will be obtained at the completion of data collection. The estimated timeframe when the survey will be completed is 24 to 48 hours.)

研究者

发起方
Scripps Translational Science Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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