Blood PressurePRESSURE CHECKNCT06122246
PRESSURE CHECK: Find Your Path to Better Health
A study testing Community Health Worker (CHW) and Remote Blood Pressure (BP) Management Program (RBPM) in people with Blood Pressure, run by Yale University at 4 sites in United States.
Trial summary
This study seeks to develop the evidence for a sustainable, community-partnered, multi-level health system strategy to improve blood pressure control. Two team-based approaches are being tested: 1) a medical model of remote BP management (RBPM) alone, and 2) RBPM plus a social model with a community health worker… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Community Health Worker (CHW) and Remote Blood Pressure (BP) Management Program (RBPM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Apr 2024to 31 Aug 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elevated BP, defined as an average resting BP of >=135/85 mmHg based on 3 consecutive blood pressure readings
Who cannot join
- People who are pregnant or who plan to become pregnant in the next 6 months at study entry
- Those that have end stage renal disease on dialysis
- People receiving active chemotherapy
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
Massachusetts General Brigham Hospital
Boston, Massachusetts, 02199
- Not yet recruiting
Houston Methodist
Houston, Texas, 77030
- Recruiting
Yale
New Haven, Connecticut, 06520
- Recruiting
Sentara Health
Norfolk, Virginia, 23502
About this study
This study seeks to develop the evidence for a sustainable, community-partnered, multi-level health system strategy to improve blood pressure control. Two team-based approaches are being tested: 1) a medical model of remote BP management (RBPM) alone, and 2) RBPM plus a social model with a community health worker (CHW). These 2 strategies are being compared with a standard community screening program with referral to primary care.
Read the detailed description
In this comparative effectiveness trial, we aim to answer the research question of whether a remote blood pressure management program (RBPM, inclusive of home blood pressure monitoring and telehealth visits with a nurse or pharmacist delivering protocol-supported BP management, inclusive of medications and lifestyle modifications) alone or an RBPM program with community health worker (CHW) support is more effective than standard screening with education and referral to primary care in controlling blood pressure and addressing social determinants that lead to poor health outcomes.
This is a multisite study using a stepped wedge design. Health systems in 4 different cities are each partnered with 10 community based organizations (CBOs). CBOs are randomized into one of 4 sequences. Each sequence moves through the 3 study arms at different time points: Community Standard, RBPM alone, and RBPM+CHW.
At the CBOs, research health advocates screen for hypertension. Qualifying individuals who provide informed consent can enroll in the study and are assigned to the intervention that the CBO is in at that particular time. All participants receive a blood pressure cuff and a device that syncs their data with the research database. If enrolled in the RBPM arm, participants are scheduled for telehealth visits with the Pressure Check medical team to improve blood pressure control through lifestyle support and medication initiation/titration. If enrolled in the RBPM+CHW arm, participants additionally receive support from a CHW to help with medical visits and address social determinants of health. The primary outcome is blood pressure control at 6 months. Additional outcomes include implementation science to understand factors associated with adoption and outcomes, and 12 and 18 month blood pressure control.
In partnering with the community, health systems can extend their reach. CBO leaders support health messaging around hypertension and increase trust between the health system and their clients (patients). The two models, RBPM alone and RBPM+CHW, are based on the concept that disparities in hypertension control among Black, Latinx, and low-income populations exist because of inequities related to health system access and trust, individual-level socioeconomic and lifestyle factors, the physical/built environment, sociocultural factors, and discriminatory policies. Addressing these barriers may improve blood pressure control.
- Conditions
- Blood Pressure
- Being tested
- Community Health Worker (CHW), Remote Blood Pressure (BP) Management Program (RBPM)
- Keywords
- hypertension, remote patient monitoring, community health worker, digital health
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker (CHW)Behavioural
Participants will receive the additional support of a Community Health Worker (CHW); specific activities include: support with home BP monitoring, reminders to attend RBPM clinical visits, and support with social issues impacting health (e.g., food insecurity; transportation; housing instability).
Remote Blood Pressure (BP) Management Program (RBPM)Other
Participants will receive a medical model of remote BP management (RBPM). Care is guided by protocols based on ACC/AHA High Blood Pressure Guidelines. This may include medications and/or lifestyle modifications, as is clinically indicated and personalized to each participant using principles of shared decision making.
| Study group | Role | What they receive |
|---|---|---|
| Remote Blood Pressure (BP) Management Program | Active comparator | Participants are enrolled in a remote BP management program (RBPM) inclusive of home BP monitoring and telehealth visits with a nurse or pharmacist. As part of the RBPM component, participants receive routine clinical care, guided by protocols based on ACC/AHA High Blood Pressure Guidelines. This may include medications and/or lifestyle modifications, as is clinically indicated and personalized to each participant using principles of shared decision making. The duration of the intervention is 6 months, after which they are referred back to their PCP. Enrollment and graduation letters are sent to the PCP and care transitions are coordinated. Receives: Other: Remote Blood Pressure (BP) Management Program (RBPM) |
| Remote Blood Pressure (BP) Management Program + Community Health Worker (CHW) | Experimental | Participants are enrolled in a remote BP management program (RBPM) inclusive of home BP monitoring and telehealth visits with a Pressure Check nurse or pharmacist plus a social model with a CHW. As part of the RBPM component, participants receive routine clinical care, guided by protocols based on ACC/AHA High Blood Pressure Guidelines. This may include medications and/or lifestyle modifications, as is clinically indicated and personalized to each participant using principles of shared decision making. As part of the CHW component, participants receive support with home BP monitoring, reminders to attend RBPM clinical visits, and support with social issues impacting health (e.g., food insecurity; transportation; housing instability). The duration of the intervention is 6 months, after which they are referred back to their PCP. Enrollment and graduation letters are sent to the PCP and care transitions are coordinated. Receives: Behavioral: Community Health Worker (CHW); Other: Remote Blood Pressure (BP) Management Program (RBPM) |
| Usual Care | No intervention | Participants receive education about hypertension and are referred to primary care for ongoing management. If a participant does not have a PCP, they receive assistance making an appointment with a new PCP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Control
Participants will be assessed at 6 months for Blood Pressure (BP) control- defined as BP <130/80 mmHg. To assess BP control, blood pressure will be measured in-person at the CBO (or another location) at Baseline, 6, 12 and 18 months with the primary endpoint of assessment as BP control at 6 months.
Measured: 6 months
Secondary outcomes (4)
Difference in systolic BP between study groups, measured at CBO
Mean difference in BP measured at CBO at baseline and follow-up; take average of last 2 of 3 measurements
Measured: 6 months, 12 months, 18 months
Difference in BP control by study group, measured at CBO
Proportion of participants with BP with:
Ideal <120/80 mmHg Intermediate: <=135/85 mmHg Poor: >135/85mmHg
Measured: 6 months, 12 months, 18 months
Change in Well-being
Well-being is assessed with the 12-item 100 Million Healthier Lives. Cantrill's Ladder: stratification into Thriving, Suffering, Struggling. Will assess mean differences of 0.5 as meaningfully different
Measured: 6 months, 12 months, 18 months
Change in Lifestyle behaviors
Differences in self-reported measures using a survey.Each measure is categorized as "ideal"(2 points), "intermediate"(1 point) or "poor" (0 point).
Measured: 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start14 Apr 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Yale 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Community Based Organizations (CBO) will be randomized in a cluster-randomized stepped-wedge design in which CBOs will be randomized to one of 5 sequences.
- Masking
- None (open label)
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Erica Spatz, MD, Principal investigator, Yale UniversityRafael Perez-Escamilla, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122246
- Sponsor's protocol ID
- 2000036141
- Other IDs
- HM-2022C2-28354
- Acronym
- PRESSURE CHECK
- Status last verified
- Mar 2026
- First submitted
- 2 Nov 2023
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After investigators complete the main reports, data will be shared upon request. When sharing data with other collaborators and the broader scientific community, all identifiers will be removed.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRESSURE CHECK: Find Your Path to Better Health
- ClinicalTrials.gov ID
- NCT06122246
- Acronym / sponsor ID
- PRESSURE CHECK / 2000036141
- Conditions
- Blood Pressure
- Keywords
- hypertension, remote patient monitoring, community health worker, digital health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 14 Apr 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 8 Nov 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.
This study seeks to develop the evidence for a sustainable, community-partnered, multi-level health system strategy to improve blood pressure control. Two team-based approaches are being tested: 1) a medical model of remote BP management (RBPM) alone, and 2) RBPM plus a social model with a community health worker (CHW). These 2 strategies are being compared with a standard community screening program with referral to primary care.
Detailed description
In this comparative effectiveness trial, we aim to answer the research question of whether a remote blood pressure management program (RBPM, inclusive of home blood pressure monitoring and telehealth visits with a nurse or pharmacist delivering protocol-supported BP management, inclusive of medications and lifestyle modifications) alone or an RBPM program with community health worker (CHW) support is more effective than standard screening with education and referral to primary care in controlling blood pressure and addressing social determinants that lead to poor health outcomes.
This is a multisite study using a stepped wedge design. Health systems in 4 different cities are each partnered with 10 community based organizations (CBOs). CBOs are randomized into one of 4 sequences. Each sequence moves through the 3 study arms at different time points: Community Standard, RBPM alone, and RBPM+CHW.
At the CBOs, research health advocates screen for hypertension. Qualifying individuals who provide informed consent can enroll in the study and are assigned to the intervention that the CBO is in at that particular time. All participants receive a blood pressure cuff and a device that syncs their data with the research database. If enrolled in the RBPM arm, participants are scheduled for telehealth visits with the Pressure Check medical team to improve blood pressure control through lifestyle support and medication initiation/titration. If enrolled in the RBPM+CHW arm, participants additionally receive support from a CHW to help with medical visits and address social determinants of health. The primary outcome is blood pressure control at 6 months. Additional outcomes include implementation science to understand factors associated with adoption and outcomes, and 12 and 18 month blood pressure control.
In partnering with the community, health systems can extend their reach. CBO leaders support health messaging around hypertension and increase trust between the health system and their clients (patients). The two models, RBPM alone and RBPM+CHW, are based on the concept that disparities in hypertension control among Black, Latinx, and low-income populations exist because of inequities related to health system access and trust, individual-level socioeconomic and lifestyle factors, the physical/built environment, sociocultural factors, and discriminatory policies. Addressing these barriers may improve blood pressure control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Community Based Organizations (CBO) will be randomized in a cluster-randomized stepped-wedge design in which CBOs will be randomized to one of 5 sequences.
| Arm | Type | Receives |
|---|---|---|
| Remote Blood Pressure (BP) Management Program | Active comparator | Other: Remote Blood Pressure (BP) Management Program (RBPM)Participants are enrolled in a remote BP management program (RBPM) inclusive of home BP monitoring and telehealth visits with a nurse or pharmacist. As part of the RBPM component, participants receive routine clinical care, guided by protocols based on ACC/AHA High Blood Pressure Guidelines. This may include medications and/or lifestyle modifications, as is clinically indicated and personalized to each participant using principles of shared decision making. The duration of the intervention is 6 months, after which they are referred back to their PCP. Enrollment and graduation letters are sent to the PCP and care transitions are coordinated. |
| Remote Blood Pressure (BP) Management Program + Community Health Worker (CHW) | Experimental | Behavioral: Community Health Worker (CHW), Other: Remote Blood Pressure (BP) Management Program (RBPM)Participants are enrolled in a remote BP management program (RBPM) inclusive of home BP monitoring and telehealth visits with a Pressure Check nurse or pharmacist plus a social model with a CHW. As part of the RBPM component, participants receive routine clinical care, guided by protocols based on ACC/AHA High Blood Pressure Guidelines. This may include medications and/or lifestyle modifications, as is clinically indicated and personalized to each participant using principles of shared decision making. As part of the CHW component, participants receive support with home BP monitoring, reminders to attend RBPM clinical visits, and support with social issues impacting health (e.g., food insecurity; transportation; housing instability). The duration of the intervention is 6 months, after which they are referred back to their PCP. Enrollment and graduation letters are sent to the PCP and care transitions are coordinated. |
| Usual Care | No intervention | –Participants receive education about hypertension and are referred to primary care for ongoing management. If a participant does not have a PCP, they receive assistance making an appointment with a new PCP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elevated BP, defined as an average resting BP of >=135/85 mmHg based on 3 consecutive blood pressure readings
Key exclusion criteria (3 listed)
- People who are pregnant or who plan to become pregnant in the next 6 months at study entry
- Those that have end stage renal disease on dialysis
- People receiving active chemotherapy
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 |
|---|---|---|
| Community Health Worker (CHW)Participants will receive the additional support of a Community Health Worker (CHW); specific activities include: support with home BP monitoring, reminders to attend RBPM clinical visits, and support with social issues impacting health (e.g., food insecurity; transportation; housing instability). | Behavioural | Remote Blood Pressure (BP) Management Program + Community Health Worker (CHW) |
| Remote Blood Pressure (BP) Management Program (RBPM)Participants will receive a medical model of remote BP management (RBPM). Care is guided by protocols based on ACC/AHA High Blood Pressure Guidelines. This may include medications and/or lifestyle modifications, as is clinically indicated and personalized to each participant using principles of shared decision making. | Other | Remote Blood Pressure (BP) Management Program, Remote Blood Pressure (BP) Management Program + Community Health Worker (CHW) |
Primary outcome
Blood Pressure Control
Time frame: 6 months
Participants will be assessed at 6 months for Blood Pressure (BP) control- defined as BP <130/80 mmHg. To assess BP control, blood pressure will be measured in-person at the CBO (or another location) at Baseline, 6, 12 and 18 months with the primary endpoint of assessment as BP control at 6 months.
4 secondary outcomes
Difference in systolic BP between study groups, measured at CBO
Time frame: 6 months, 12 months, 18 months
Difference in BP control by study group, measured at CBO
Time frame: 6 months, 12 months, 18 months
Change in Well-being
Time frame: 6 months, 12 months, 18 months
Change in Lifestyle behaviors
Time frame: 6 months, 12 months, 18 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 24 Mar 2026.
- Pressure Check websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After investigators complete the main reports, data will be shared upon request. When sharing data with other collaborators and the broader scientific community, all identifiers will be removed.
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Behavior
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.
Erica Spatz, MD principal investigator
Yale University
Rafael Perez-Escamilla, MD principal investigator
Yale University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker (CHW) and Remote Blood Pressure (BP) Management Program (RBPM) in people with Blood Pressure, run by Yale University 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 Mar 2026. 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?
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?
Contact Bonnie Garmisa, MAT ((203) 640-2684, bonnie.garmisa@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Control (time frame: 6 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 24 Mar 2026.