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The PCORnet Blood Pressure Home Monitoring Study (BP Home)

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ClinicalTrials.gov Identifier: NCT03796689
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : November 17, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Device: Smartphone-linked HBPM and associated app Device: Standard HBPM Not Applicable

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. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The PCORnet Blood Pressure Home Monitoring Study
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 publically 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.

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 publically 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 Outcome Measures :
  1. Reduction in Systolic Blood Pressure (SBP) [ Time Frame: 6 months ]
    Reduction 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  • 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

Exclusion Criteria:

  • Has an arm circumference <22 cm or >42 cm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796689


Contacts
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Contact: Madelaine Faulkner, MPH 415-476-3393 Madelaine.Faulkner@ucsf.edu
Contact: Mark Pletcher, MD MPH 415-514-8008 Mark.Pletcher@ucsf.edu

Locations
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United States, Florida
University of Florida Health Recruiting
Gainesville, Florida, United States, 32610
Contact: Rhonda Cooper-Dehoff, PharmD         
United States, Louisiana
University Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Tom Carton, Ph.D         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
Contact: Alanna Chamberlain, Ph.D         
Sponsors and Collaborators
University of California, San Francisco
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Mark Pletcher, MD MPH University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03796689    
Other Study ID Numbers: 18-254-53
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases