Hypertension Clinical Trial
— BP HomeOfficial title:
The PCORnet Blood Pressure Home Monitoring Study
Verified date | October 2022 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2238 |
Est. completion date | October 23, 2021 |
Est. primary completion date | October 23, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida Health | Gainesville | Florida |
United States | University Medical Center | New Orleans | Louisiana |
United States | Mayo Clinic | Rochester | Minnesota |
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Patient-Centered Outcomes Research Institute |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Systolic Blood Pressure (SBP) | 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. | Baseline and 6 months | |
Primary | Net Promoter Score | 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. | 6 months |
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