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临床试验/NCT03661112
NCT03661112已完成不适用

A Pilot Study to Explore the Feasibility and Operational Pathways of Incorporating a Wrist-based Blood Pressure Monitoring Device Into the All of Us Research Program

Scripps Translational Science Institute1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年5月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Blood pressure measurements

研究概览

简要总结

To observe blood pressure variation in various real-world settings

详细描述

This is an observational study, which will utilize a wrist-based blood pressure monitor to explore blood pressure variation in up to 75 participants in various real-world settings. There is no intervention in this study. The study will take place over a 4-week period. During this time, participants will be asked to sample their blood pressures 1) at random times, several times per day; 2) during specific periods of either emotional stress or relaxation; 3) during guided orthostatic testing. Study participants will utilize an application on their smartphones to log the device-measured blood pressures and flag selected blood pressure measurements as either being part of the orthostatic testing or during periods of emotional stress/relaxation. At the close of the study a post-study questionnaire will be sent electronically to each participant.

研究设计

研究类型
Observational
观察模型
Other
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

  • Consortium members within the All of Us Research Program
  • ≥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

结局指标

主要结局

Blood pressure measurements

时间窗: 4 weeks

The primary endpoint for this study is assessing variability in blood pressure measurements (both systolic and diastolic). Blood pressure measurements will be sought over the course of 4 weeks during the following activities: 1. During waking hours (several times a day for at least 2 days out of the week) 2. Orthostatic maneuvers (seated and then 1 minute after standing up) 3. At times of stress and relaxation.

次要结局

未报告次要终点

研究者

发起方
Scripps Translational Science Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Evan Muse, MD, PhD

Director, Digital Medicine, Scripps Translational Science Institute

Scripps Translational Science Institute

研究点 (1)

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