Wrist-based Blood Pressure Monitoring Study

January 7, 2019 updated by: Evan Muse, MD, PhD, Scripps Translational Science Institute

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

To observe blood pressure variation in various real-world settings

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Translational Science Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Members of the All of Us Research Program (AoURP) Participant Center consortium (age > 18 years)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
All of Us Research Program (AoURP) consortium members

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Translational Science Institute

Collaborators

Omron Healthcare Co., Ltd.

Investigators

  • Principal Investigator: Evan D Muse, MD, Scripps Translational Science Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2018

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

January 8, 2019

Last Update Submitted That Met QC Criteria

January 7, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-18-7119

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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