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NCT03796689: BP Home

The PCORnet Blood Pressure Home Monitoring Study

Completed NA Results posted Last updated 16 November 2022
What this trial tests

NA trial testing Smartphone-linked HBPM and associated app in Hypertension in 2,238 participants. Completed in 23 October 2021.

Timeline
15 August 2019
Primary endpoint
23 October 2021
23 October 2021

Quick facts

Lead sponsorUniversity of California, San Francisco
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment2,238
Start date15 August 2019
Primary completion23 October 2021
Estimated completion23 October 2021
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Systolic Blood Pressure (SBP) Primary · 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.

GroupValue95% CI
Smartphone-linked10.8± 18
Standard10.6± 18
Net Promoter Score Primary · 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.

GroupValue95% CI
Smartphone-linked59± 2.81
Standard57± 4.00

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effectiveness of Standard vs Enhanced Self-measurement of Blood Pressure Paired With a Connected Smartphone Application: A Randomized Clinical Trial.
    Pletcher MJ, Fontil V, Modrow MF, Carton T, et al · · 2022 · cited 32× · PMID 35969408 · DOI 10.1001/jamainternmed.2022.3355
  2. Estimating the Hawthorne Effect in Real-World Blood Pressure Control Trials: An Analysis of the BP Home Trial.
    Rosen M, Fontil V, Faulkner Modrow M, Smith SM, et al · · 2026 · cited 1× · PMID 41820738 · DOI 10.1007/s11606-026-10249-1

Verify or expand the search:

Other recruiting trials for Hypertension

Currently open trials in the same condition.

Other University of California, San Francisco trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03796689.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing