HypertensionBP HomeNCT03796689
The PCORnet Blood Pressure Home Monitoring Study
A study testing Smartphone-linked HBPM and associated app and Standard HBPM in people with Hypertension, run by University of California, San Francisco at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Smartphone-linked HBPM and associated app and Standard HBPM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,238 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Aug 2019to 23 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Has an arm circumference <22 cm or >42 cm
- Owns a functioning HPBM and has used it in the last 3 months
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Florida Health
Gainesville, Florida, 32610
University Medical Center
New Orleans, Louisiana, 70112
Mayo Clinic
Rochester, Minnesota, 55902
University of California, San Francisco
San Francisco, California, 94143
About this study
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.
Read the 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
- Conditions
- Hypertension
- Being tested
- Smartphone-linked HBPM and associated app, Standard HBPM
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-linked HBPM and associated appDevice
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.
Standard HBPMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone-linked | Experimental | Not described Receives: Device: Smartphone-linked HBPM and associated app |
| Standard | Active comparator | Not described Receives: Device: Standard HBPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start15 Aug 2019
- Primary completion23 Oct 2021
- Study completion23 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,238 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Mark Pletcher, MD MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796689
- Sponsor's protocol ID
- 18-254-53
- Acronym
- BP Home
- Status last verified
- Oct 2022
- First submitted
- 4 Jan 2019
- Last updated
- 16 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 11129362Hamilton 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.
PubMed 24788496Krol 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.
PubMed 25345554Pletcher 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.
PubMed 35969408Rosen M, Fontil V, Faulkner Modrow M, Smith SM, Carton TW, Chamberlain AM, O'Brien EC, Park S, Orozco J, Cooper DeHoff RM, Wozniak G, Rakotz M, McCulloch CE, Pletcher MJ. Estimating the Hawthorne Effect in Real-World Blood Pressure Control Trials: An Analysis of the BP Home Trial. J Gen Intern Med. 2026 Mar 12. doi: 10.1007/s11606-026-10249-1. Online ahead of print.
PubMed 41820738
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PCORnet Blood Pressure Home Monitoring Study
- ClinicalTrials.gov ID
- NCT03796689
- Acronym / sponsor ID
- BP Home / 18-254-53
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,238 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 23 Oct 2021 (actual)
- Study completion
- 23 Oct 2021 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Posted 16 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone-linked | Experimental | Device: Smartphone-linked HBPM and associated app |
| Standard | Active comparator | Device: Standard HBPM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (2 listed)
- Has an arm circumference <22 cm or >42 cm
- Owns a functioning HPBM and has used it in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-linked HBPM and associated appParticipants 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. | Device | Smartphone-linked |
| Standard HBPMParticipants 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. | Device | Standard |
Primary outcome
Change in Systolic Blood Pressure (SBP)
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11129362Adler 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.
- Background: PubMed 24788496Hamilton 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.
- Background: PubMed 25345554Krol 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.
- Results publication: PubMed 35969408Pletcher 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.
- Derived from this study: PubMed 41820738Rosen M, Fontil V, Faulkner Modrow M, Smith SM, Carton TW, Chamberlain AM, O'Brien EC, Park S, Orozco J, Cooper DeHoff RM, Wozniak G, Rakotz M, McCulloch CE, Pletcher MJ. Estimating the Hawthorne Effect in Real-World Blood Pressure Control Trials: An Analysis of the BP Home Trial. J Gen Intern Med. 2026 Mar 12. doi: 10.1007/s11606-026-10249-1. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Pletcher, MD MPH principal investigator
University of California, San Francisco
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-linked HBPM and associated app and Standard HBPM in people with Hypertension, run by University of California, San Francisco at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure (SBP) (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03796689, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.