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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Blood Pressure
- Sponsor
- Scripps Translational Science Institute
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Blood pressure measurements
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
To observe blood pressure variation in various real-world settings
Detailed Description
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.
Investigators
Evan Muse, MD, PhD
Director, Digital Medicine, Scripps Translational Science Institute
Scripps Translational Science Institute
Eligibility Criteria
Inclusion Criteria
- •Consortium members within the All of Us Research Program
- •≥18 years of age
- •Own an iOS or Android device
Exclusion Criteria
- •Inability to give informed consent
- •\<18 years of age
- •Inability to understand written English language
Outcomes
Primary Outcomes
Blood pressure measurements
Time Frame: 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.