Summary

for people ages 18 years and up (full criteria)
study started
estimated completion
Mark Pletcher

Description

Summary

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.

Details

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. We aim to enroll 2000 patients who will be randomized in a 1:1 ratio to receive a Smartphone-linked or standard HBPM. 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.

Keywords

Hypertension Smartphone-linked HBPM and associated app Standard HBPM Smartphone-linked

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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)
  • Nobody in household currently owns a HBPM
  • 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

You CAN'T join if...

  • Has an arm circumference <9 inches or >17 inches

Lead Scientist

  • Mark Pletcher
    As an epidemiologist and a general internal medicine physician, my research is designed to inform clinical decision-making and policy relevant to primary care and prevention.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03796689
Study Type
Interventional
Last Updated