The PCORnet Blood Pressure Home Monitoring Study (BP Home)

October 24, 2022 updated by: University of California, San Francisco
The PCORnet Blood Pressure Home Monitoring (BP HOME) Study is a patient-level randomized controlled trial that will compare the effectiveness of home blood pressure monitoring (HPBM) with versus without a linked Smartphone application ("app") for helping patients with uncontrolled hypertension achieve a reduction in systolic blood pressure. The trial will be conducted within the National Patient-Centered Clinical Research Network (PCORnet), which supports a research network that enables distributed querying of EHR data in a common data model. It will also use the Eureka Research Platform, an online research platform hosted by UCSF that supports eConsent, online surveys, and data collection from devices such as HBPMs. Data from these two data sources will be used together to accomplish the study aims. Given that HBPM is the guideline-recommended standard of care (without specification of Smartphone linkage), the HPBM devices and the app are all commercially available and currently in use, and that clinicians, with input from patients, will maintain full control of how BP is clinically managed, we believe participation in the project poses minimal risk to participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We have designed a patient-level randomized controlled trial that will compare the effectiveness of Smartphone-linked versus standard HBPM for helping patients with uncontrolled hypertension achieve a reduction in their Systolic Blood Pressure (SBP), and patient satisfaction with the device. Our original plan was to recruit 2000 patients who would be randomized in a 1:1 ratio to receive a Smartphone-linked or standard HBPM. However, to recruit higher diversity with more African Americans and LatinX patients, we extended the recruitment period.* We will use data from the electronic health record (EHR), an online patient portal, and the home BP monitor (in the Smartphone-linked arm) to collect outcome data for a period of at least 6 months (for the primary outcome), and up to 18 months (for secondary outcomes, depending on enrollment date). The primary BP control outcome will be reduction in SBP, by clinic measurements, at 6 months. The primary patient satisfaction outcome will be the Net Promoter Score derived from self-reported likelihood of recommending the device to a friend, at 6 months.

*edited after completing recruitment

Study Type

Interventional

Enrollment (Actual)

2238

Phase

  • Not Applicable

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
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida Health
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • At least one ambulatory visit in one of the participating study sites during the past year
  • SBP > 145 mmHg at most recent clinic visit (may be treated with BP meds already or not)
  • A self-reported commitment to "work on lowering your blood pressure by 10 points or more to reduce your risk of heart attack and stroke"
  • Owns a Smartphone (Android or iOS)
  • Willing to receive text messages from the study
  • Can read/write English well enough to use English-based Smartphone apps and fill out online surveys in English

Exclusion Criteria:

  • Has an arm circumference <22 cm or >42 cm
  • Owns a functioning HPBM and has used it in the last 3 months

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard
Device: Standard HBPM
Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider.
Experimental: Smartphone-linked
Device: Smartphone-linked HBPM and associated app
Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Systolic Blood Pressure (SBP)
Time Frame: Baseline and 6 months
Change is defined by the absolute difference between the SBP measured at the most recent outpatient clinical encounter at the time of enrollment, and the SBP measured at the most recent outpatient clinical encounter 6 months after enrollment. If more than 1 measurement is recorded during a single clinical encounter, the lower/lowest will be used.
Baseline and 6 months
Net Promoter Score
Time Frame: 6 months
This score is assessed by asking a single question about likelihood of recommending the device to a friend, with options from 1-10 (10 being extremely likely). As per published methods, persons indicating 9 or 10 are considered "Promoters"; persons indicating 7 or 8 are "Passives"; and persons indicating 1-6 are "Detractors". The score is calculated by taking the percent of Promoters and subtracting the percent of Detractors, yielding a score for each group ranging from -100 to 100, with higher scores indicating a better outcome.
6 months

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Mark Pletcher, MD MPH, University of California, San Francisco

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)

August 15, 2019

Primary Completion (Actual)

October 23, 2021

Study Completion (Actual)

October 23, 2021

Study Registration Dates

First Submitted

January 4, 2019

First Submitted That Met QC Criteria

January 4, 2019

First Posted (Actual)

January 8, 2019

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-254-53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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