The PCORnet Blood Pressure Home Monitoring Study (BP Home)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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. Our original plan was to recruit 2000 patients who would be randomized in a 1:1 ratio to receive a Smartphone-linked or standard HBPM. However, to recruit higher diversity with more African Americans and LatinX patients, we extended the recruitment period.* 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.
*edited after completing recruitment
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
2,238 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal