Clinical trial NCT03796689: The PCORnet Blood Pressure Home Monitoring Study
Official title: The PCORnet Blood Pressure Home Monitoring Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2019-01-08
Enrollment: 2238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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. 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

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 \<22 cm or \>42 cm
* Owns a functioning HPBM and has used it in the last 3 months

Primary outcomes:
measure: Change in Systolic Blood Pressure (SBP)
timeFrame: Baseline and 6 months
measure: Net Promoter Score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: New Orleans
country: United States
facility: University Medical Center
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: University of California, San Francisco
name: Mark Pletcher, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adler NE, Epel ES, Castellazzo G, Ickovics JR. Relationship of subjective and objective social status with psychological and physiological functioning: preliminary data in healthy white women. Health Psychol. 2000 Nov;19(6):586-92. doi: 10.1037//0278-6133.19.6.586.
citation: Hamilton DF, Lane JV, Gaston P, Patton JT, Macdonald DJ, Simpson AH, Howie CR. Assessing treatment outcomes using a single question: the net promoter score. Bone Joint J. 2014 May;96-B(5):622-8. doi: 10.1302/0301-620X.96B5.32434.
citation: Krol MW, de Boer D, Delnoij DM, Rademakers JJ. The Net Promoter Score--an asset to patient experience surveys? Health Expect. 2015 Dec;18(6):3099-109. doi: 10.1111/hex.12297. Epub 2014 Oct 27.
citation: Pletcher MJ, Fontil V, Modrow MF, Carton T, Chamberlain AM, Todd J, O'Brien EC, Sheer A, Vittinghoff E, Park S, Orozco J, Lin F, Maeztu C, Wozniak G, Rakotz M, Shay CM, Cooper-DeHoff RM. Effectiveness of Standard vs Enhanced Self-measurement of Blood Pressure Paired With a Connected Smartphone Application: A Randomized Clinical Trial. JAMA Intern Med. 2022 Oct 1;182(10):1025-1034. doi: 10.1001/jamainternmed.2022.3355.