Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1440 participants
INTERVENTIONAL
2024-04-14
2027-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Remote Blood Pressure (BP) Management Program
Participants are enrolled in a remote BP management program (RBPM) inclusive of home BP monitoring and telehealth visits with a nurse or pharmacist.
Remote Blood Pressure (BP) Management Program (RBPM)
Participants will receive a medical model of remote BP management (RBPM).
Remote Blood Pressure (BP) Management Program + Community Health Worker (CHW)
Participants are enrolled in a remote BP management program (RBPM) inclusive of home BP monitoring and telehealth visits with a nurse or pharmacist plus a social model with a CHW.
Community Health Worker (CHW)
Participants will receive the additional support of a Community Health Worker (CHW).
Remote Blood Pressure (BP) Management Program (RBPM)
Participants will receive a medical model of remote BP management (RBPM).
Usual Care
Participants receive education about hypertension and are referred to primary care for ongoing management.
No interventions assigned to this group
Interventions
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Community Health Worker (CHW)
Participants will receive the additional support of a Community Health Worker (CHW).
Remote Blood Pressure (BP) Management Program (RBPM)
Participants will receive a medical model of remote BP management (RBPM).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Those that have end stage renal disease on dialysis
* People receiving active chemotherapy
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Yale University
OTHER
Responsible Party
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Principal Investigators
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Erica Spatz, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Rafael Perez-Escamilla, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale
New Haven, Connecticut, United States
Massachusetts General Brigham Hospital
Boston, Massachusetts, United States
Houston Methodist
Houston, Texas, United States
Sentara Health
Norfolk, Virginia, United States
Countries
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Central Contacts
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Related Links
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Pressure Check website
Other Identifiers
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HM-2022C2-28354
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2000036141
Identifier Type: -
Identifier Source: org_study_id
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