N/A
Completed N=2,101
The PCORnet Blood Pressure Home Monitoring Study
Source: ClinicalTrials.gov NCT03796689 ↗Enrolled (actual)
2,101
Serious AEs
—
Results posted
Nov 2022
Primary outcomePrimary: Change in Systolic Blood Pressure (SBP) — 10.8; 10.6 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Systolic Blood Pressure (SBP) |
10.8; 10.6 | — |
| PRIMARY Net Promoter Score |
59; 57 | — |
Eligibility 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)
- 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 42 cm
- Owns a functioning HPBM and has used it in the last 3 months
Data sourced from ClinicalTrials.gov (NCT03796689). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.