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Completed

NCT Number: NCT03796689

The PCORnet Blood Pressure Home Monitoring Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, San Francisco, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone-linked HBPM and associated app

Device

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.

Standard HBPM

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Acronym: BP Home

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 8, 2019
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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