HypertensionMonitorBPNCT05885997
Implementing a Home Blood Pressure Monitoring Program in Primary Care
A study testing Supported HBPM program plus multifaceted implementation strategy in people with Hypertension, run by Columbia University at 2 sites in United States.
Trial summary
The goal of this research is to determine whether a theory-informed implementation strategy is successful at increasing the uptake of a supported home blood pressure monitoring (HBPM) program as well as to determine the effectiveness of this evidence-based practice when implemented across multiple practices serving a… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Supported HBPM program plus multifaceted implementation strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23,928 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertension (as per International Statistical Classification of Diseases and Related Health Problems (ICD)-10 codes)
- At least one completed primary care office visit during relevant 6-month pre implementation or post-implementation study time period
- Age 18-85 years old
- Primary care practice that provides care to adult patients affiliated with New York Presbyterian's Ambulatory Care Network, ColumbiaDoctors, or Weill Cornell Medicine, including practices that specialize in HIV medicine
Who cannot join
- Advanced dementia or other measure of frailty (as per ICD-10 codes)
- Pregnancy during measurement period (as per ICD-10 codes)
- Stage 5 or end-stage kidney disease (as per ICD-10 codes)
- Terminal illness/in hospice care (as per ICD-10 codes)
- Practice-level
- Medical director declines participation in the trial
- Site for pilot testing the supported HBPM program or its implementation strategy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University Irving Medical Center
New York, New York, 10032
Weill Medical College of Cornell University
New York, New York, 10065
About this study
Official title: Implementing a Home Blood Pressure Monitoring Program to Improve Hypertension Control in a Primary Care Network: the MonitorBP Cluster Randomized Trial
The goal of this research is to determine whether a theory-informed implementation strategy is successful at increasing the uptake of a supported home blood pressure monitoring (HBPM) program as well as to determine the effectiveness of this evidence-based practice when implemented across multiple practices serving a diverse patient population.
Read the detailed description
Hypertension guidelines now strongly recommend that patients with hypertension monitor their blood pressure (BP) at home (i.e., home BP monitoring; HBPM) as an approach to improving BP control so long as HBPM is conducted with clinical support (i.e., supported HBPM). Yet, few health systems have systematically implemented HBPM programs, and less than 20% of hypertensive patients routinely measure their BP at home, resulting in a gap in the translation of evidence-based recommendations into practice.
While there is strong evidence for Supported HBPM from pragmatic randomized controlled trials (RCTs), the evidence has been generated from the subgroup of patients and clinicians who volunteered to participate in trials, and the sample sizes have been in the hundreds of patients. There remains a gap in assessing the effectiveness of a scaled-up HBPM program that seeks to maximize the enrollment of primary care patients with uncontrolled hypertension.
Accordingly, in partnership with health system leaders at New York-Presbyterian Hospital (NYP), Columbia University Irving Medical Center, and Weill Cornell Medicine, the study investigator leveraged a system-wide investment in telemedicine to develop a telemonitoring-enabled Supported HBPM program. The Supported HBPM program consists of two options for obtaining electronic health record (EHR)-integrated home BP data. The low resource intensity option is designed for patients that can obtain valid home BP devices and are comfortable using the patient portal. It includes digital support to prompt patients to track their home BP readings in the patient portal using their own BP devices with automated triage support for extreme readings. The high resource intensity option is designed for patients that need additional support with HBPM. It involves navigator support with obtaining and using loaned home BP devices that wirelessly transmit data into the EHR and nursing support to triage extreme readings. Both programs can be ordered by clinicians in the EHR and both provide clinicians with weekly summaries of home BP readings with average home BP already calculated.
The study investigator concurrently followed a theory-driven process (the Behavior Change Wheel) to develop an implementation strategy aimed at increasing uptake of the Supported HBPM program. The study investigator now plans to implement and evaluate the Supported HBPM program across practices in the NYP, Weill Cornell Medicine, and ColumbiaDoctors primary care network which is comprised of a socioeconomically diverse patient population.
The study will evaluate the program by conducting a parallel-group cluster randomized trial in which 15 practices will be matched and then randomly assigned to early implementation of the Supported HBPM program (intervention) versus usual care with delayed implementation (i.e., wait-list control). Data will be retrospectively collected from a 12 month period before implementation (pre-implementation periods) as well as from a 12 month period after implementation (post-implementation period) to assess outcomes.
If successful, this project will provide a roadmap for widely implementing an EHR-integrated Supported HBPM program, and will accelerate a change in the paradigm of hypertension management from the office to the home.
- Conditions
- Hypertension
- Being tested
- Supported HBPM program plus multifaceted implementation strategy, Usual care
- Keywords
- home blood pressure monitoring, remote patient monitoring, self-measured blood pressure monitoring, implementation science
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supported HBPM program plus multifaceted implementation strategyBehavioural
Supported HBPM Program:
- Patients are loaned a wireless home BP device or use their own device
- Navigator or app support for onboarding and engaging patients in HBPM
- Nursing or app support for monitoring and triaging home BP data for extreme readings
- EHR integration of order for program and home BP data, with weekly feedback of home BP results to clinicians within the EHR
Multifaceted implementation strategy:
- Clinician education about the benefits of the program as well as training in how to refer and manage patients who are enrolled
- Prompts and reminders to increase clinician referrals
- Instructional materials for patients and clinicians
- Problem-solving meetings to tailor implementation for individual practices
Usual careOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Intervention Clinics, Pre-Implementation Period | Experimental | Usual care Receives: Other: Usual care |
| Intervention Clinics, Post-Implementation Period | Experimental | Access to Supported HBPM program plus a multifaceted implementation strategy designed to increase uptake of the program by primary care patients with uncontrolled hypertension Receives: Behavioral: Supported HBPM program plus multifaceted implementation strategy |
| Control Clinics, Pre-Implementation Period | Other | Usual care Receives: Other: Usual care |
| Control Clinics, Post-Implementation Period | Other | Usual care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient's office systolic blood pressure (SBP)
Change in patient's office systolic blood pressure (SBP) from index visit to last visit during the subsequent 12 months, among patients with uncontrolled hypertension at the index visit
Measured: 12 months
Secondary outcomes (4)
Office diastolic blood pressure (DBP)
Change in patient's office diastolic blood pressure (DBP) from index visit to last visit during the subsequent 12 months, among patients with uncontrolled hypertension at the index visit
Measured: 12 months
Change in patient's antihypertensive medication regimen intensity
Change in patient's antihypertensive medication regimen intensity as calculated by the Therapeutic Intensity Score from index visit to last visit during the subsequent 12 months, among patients with uncontrolled hypertension at the index visit
Measured: 12 months
Antihypertensive medication adherence
Change in the proportion of days covered by antihypertensive medications from the 6 months prior to the index visit to the last 6 months of the 12-month follow-up period, among patients with uncontrolled hypertension at the index visit. Antihypertensive medication adherence will be calculated for each prescribed class of medication and then averaged across all classes.
Measured: 12 months
Uncontrolled hypertension
Percentage of patients whose last office BP during the 12-month follow-up period was SBP>= 140 mmHg or DBP >= 90 mmHg, among all eligible patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Nov 2023
- Primary completion20 Oct 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23,928 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, New York Presbyterian Hospital, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ian Kronish, Columbia University
- Investigators
- Ian Kronish, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885997
- Sponsor's protocol ID
- AAAS5544
- Other IDs
- R01HL152699
- Acronym
- MonitorBP
- Status last verified
- Oct 2026
- First submitted
- 23 May 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified data archive that contains raw study data will be posted on an open science platform.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Home Blood Pressure Monitoring Program to Improve Hypertension Control in a Primary Care Network: the MonitorBP Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT05885997
- Acronym / sponsor ID
- MonitorBP / AAAS5544
- Conditions
- Hypertension
- Keywords
- home blood pressure monitoring, remote patient monitoring, self-measured blood pressure monitoring, implementation science
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23,928 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, New York Presbyterian Hospital, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 20 Oct 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research is to determine whether a theory-informed implementation strategy is successful at increasing the uptake of a supported home blood pressure monitoring (HBPM) program as well as to determine the effectiveness of this evidence-based practice when implemented across multiple practices serving a diverse patient population.
Detailed description
Hypertension guidelines now strongly recommend that patients with hypertension monitor their blood pressure (BP) at home (i.e., home BP monitoring; HBPM) as an approach to improving BP control so long as HBPM is conducted with clinical support (i.e., supported HBPM). Yet, few health systems have systematically implemented HBPM programs, and less than 20% of hypertensive patients routinely measure their BP at home, resulting in a gap in the translation of evidence-based recommendations into practice.
While there is strong evidence for Supported HBPM from pragmatic randomized controlled trials (RCTs), the evidence has been generated from the subgroup of patients and clinicians who volunteered to participate in trials, and the sample sizes have been in the hundreds of patients. There remains a gap in assessing the effectiveness of a scaled-up HBPM program that seeks to maximize the enrollment of primary care patients with uncontrolled hypertension.
Accordingly, in partnership with health system leaders at New York-Presbyterian Hospital (NYP), Columbia University Irving Medical Center, and Weill Cornell Medicine, the study investigator leveraged a system-wide investment in telemedicine to develop a telemonitoring-enabled Supported HBPM program. The Supported HBPM program consists of two options for obtaining electronic health record (EHR)-integrated home BP data. The low resource intensity option is designed for patients that can obtain valid home BP devices and are comfortable using the patient portal. It includes digital support to prompt patients to track their home BP readings in the patient portal using their own BP devices with automated triage support for extreme readings. The high resource intensity option is designed for patients that need additional support with HBPM. It involves navigator support with obtaining and using loaned home BP devices that wirelessly transmit data into the EHR and nursing support to triage extreme readings. Both programs can be ordered by clinicians in the EHR and both provide clinicians with weekly summaries of home BP readings with average home BP already calculated.
The study investigator concurrently followed a theory-driven process (the Behavior Change Wheel) to develop an implementation strategy aimed at increasing uptake of the Supported HBPM program. The study investigator now plans to implement and evaluate the Supported HBPM program across practices in the NYP, Weill Cornell Medicine, and ColumbiaDoctors primary care network which is comprised of a socioeconomically diverse patient population.
The study will evaluate the program by conducting a parallel-group cluster randomized trial in which 15 practices will be matched and then randomly assigned to early implementation of the Supported HBPM program (intervention) versus usual care with delayed implementation (i.e., wait-list control). Data will be retrospectively collected from a 12 month period before implementation (pre-implementation periods) as well as from a 12 month period after implementation (post-implementation period) to assess outcomes.
If successful, this project will provide a roadmap for widely implementing an EHR-integrated Supported HBPM program, and will accelerate a change in the paradigm of hypertension management from the office to the home.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention Clinics, Pre-Implementation Period | Experimental | Other: Usual careUsual care |
| Intervention Clinics, Post-Implementation Period | Experimental | Behavioral: Supported HBPM program plus multifaceted implementation strategyAccess to Supported HBPM program plus a multifaceted implementation strategy designed to increase uptake of the program by primary care patients with uncontrolled hypertension |
| Control Clinics, Pre-Implementation Period | Other | Other: Usual careUsual care |
| Control Clinics, Post-Implementation Period | Other | Other: Usual careUsual care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hypertension (as per International Statistical Classification of Diseases and Related Health Problems (ICD)-10 codes)
- At least one completed primary care office visit during relevant 6-month pre implementation or post-implementation study time period
- Age 18-85 years old
- Primary care practice that provides care to adult patients affiliated with New York Presbyterian's Ambulatory Care Network, ColumbiaDoctors, or Weill Cornell Medicine, including practices that specialize in HIV medicine
Key exclusion criteria (7 listed)
- Advanced dementia or other measure of frailty (as per ICD-10 codes)
- Pregnancy during measurement period (as per ICD-10 codes)
- Stage 5 or end-stage kidney disease (as per ICD-10 codes)
- Terminal illness/in hospice care (as per ICD-10 codes)
- Practice-level
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 |
|---|---|---|
| Supported HBPM program plus multifaceted implementation strategySupported HBPM Program: * Patients are loaned a wireless home BP device or use their own device * Navigator or app support for onboarding and engaging patients in HBPM * Nursing or app support for monitoring and triaging home BP data for extreme readings * EHR integration of order for program and home BP data, with weekly feedback of home BP results to clinicians within the EHR Multifaceted implementation strategy: * Clinician education about the benefits of the program as well as training in how to refer and manage patients who are enrolled * Prompts and reminders to increase clinician referrals * Instructional materials for patients and clinicians * Problem-solving meetings to tailor implementation for individual practices | Behavioural | Intervention Clinics, Post-Implementation Period |
| Usual careUsual care | Other | Control Clinics, Post-Implementation Period, Control Clinics, Pre-Implementation Period, Intervention Clinics, Pre-Implementation Period |
Primary outcome
Change in patient's office systolic blood pressure (SBP)
Time frame: 12 months
Change in patient's office systolic blood pressure (SBP) from index visit to last visit during the subsequent 12 months, among patients with uncontrolled hypertension at the index visit
4 secondary outcomes
Office diastolic blood pressure (DBP)
Time frame: 12 months
Change in patient's antihypertensive medication regimen intensity
Time frame: 12 months
Antihypertensive medication adherence
Time frame: 12 months
Uncontrolled hypertension
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Yes. A de-identified data archive that contains raw study data will be posted on an open science platform.
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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.
Ian Kronish, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supported HBPM program plus multifaceted implementation strategy in people with Hypertension, run by Columbia University at 2 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
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 patient's office systolic blood pressure (SBP) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2026.