Wrist-based Blood Pressure Monitoring Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03661112

Enrollment

Registered

2018-09-07

Start date

2018-05-07

Completion date

2018-12-31

Last updated

2019-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Keywords

blood pressure, mobile device

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Blood pressure measurements	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.

Countries

United States

Outcome results