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
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
- 是
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
Evan Muse, MD, PhD
Director, Digital Medicine, Scripps Translational Science Institute
Scripps Translational Science Institute
