Hypertension
Conditions
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
Interventions
DEVICESmartphone-linked HBPM and associated app
Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app.
DEVICEStandard HBPM
Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider.
Sponsors
Patient-Centered Outcomes Research Institute
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure (SBP) | 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. |
| Net Promoter Score | 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. |
Countries
United States
Participant flow
Recruitment details
Patients meeting screening criteria were invited to participate by mail, email, phone, patient portal message or in person, and directed to the online study portal for eligibility assessment. The first participant was enrolled on August 15, 2019 and the last participant was enrolled on December 31, 2020.
Pre-assignment details
137 participants who withdrew consent prior to randomization or did not complete their baseline surveys were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Smartphone-linked Smartphone-linked HBPM and associated app: Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app. | 1,051 |
| Standard Standard HBPM: Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider. | 1,050 |
| Total | 2,101 |
Baseline characteristics
| Characteristic | Standard | Smartphone-linked | Total |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 13 | 59 years STANDARD_DEVIATION 13 | 58 years STANDARD_DEVIATION 13 |
| Comfort using technology like a computer or smartphone | 4.1 units on a scale STANDARD_DEVIATION 1.1 | 4.1 units on a scale STANDARD_DEVIATION 1.1 | 4.1 units on a scale STANDARD_DEVIATION 1.1 |
| Eligibility diastolic BP | 88 mmHg STANDARD_DEVIATION 12 | 88 mmHg STANDARD_DEVIATION 11 | 88 mmHg STANDARD_DEVIATION 12 |
| Eligibility systolic BP | 158 mmHg STANDARD_DEVIATION 12 | 157 mmHg STANDARD_DEVIATION 11 | 157 mmHg STANDARD_DEVIATION 11 |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic/LatinX, any race | 101 Participants | 79 Participants | 180 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic Asian | 22 Participants | 6 Participants | 28 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic Black | 226 Participants | 239 Participants | 465 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic, other/multiple races | 35 Participants | 51 Participants | 86 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic White | 666 Participants | 676 Participants | 1342 Participants |
| Satisfaction with BP management Overall | 3.7 units on a scale STANDARD_DEVIATION 1.2 | 3.8 units on a scale STANDARD_DEVIATION 1.1 | 3.8 units on a scale STANDARD_DEVIATION 1.2 |
| Satisfaction with BP management Your BP medications | 3.7 units on a scale STANDARD_DEVIATION 1.2 | 3.7 units on a scale STANDARD_DEVIATION 1.2 | 3.7 units on a scale STANDARD_DEVIATION 1.2 |
| Satisfaction with BP management Your healthcare provider | 4.3 units on a scale STANDARD_DEVIATION 1 | 4.3 units on a scale STANDARD_DEVIATION 1.1 | 4.3 units on a scale STANDARD_DEVIATION 1 |
| Sex/Gender, Customized Sex, female | 602 Participants | 589 Participants | 1191 Participants |
| Sex/Gender, Customized Sex, male | 448 Participants | 462 Participants | 910 Participants |
| Subjective Social Status | 6.2 units on a scale STANDARD_DEVIATION 2.2 | 6.2 units on a scale STANDARD_DEVIATION 2.2 | 6.2 units on a scale STANDARD_DEVIATION 2.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smartphone-linked | Change in Systolic Blood Pressure (SBP) | 10.8 mmHg | Standard Deviation 18 |
| Standard | Change in Systolic Blood Pressure (SBP) | 10.6 mmHg | Standard Deviation 18 |
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smartphone-linked | Net Promoter Score | 59 score on a scale | Standard Deviation 2.81 |
| Standard | Net Promoter Score | 57 score on a scale | Standard Deviation 4 |