PRESSURE CHECK: Find Your Path to Better Health (PRESSURE CHECK)

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Pressure
• Intervention / Treatment: Other: Remote Blood Pressure (BP) Management Program (RBPM); Behavioral: Community Health Worker (CHW)

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 Type: Interventional
• Enrollment (Estimated): 1440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jocelyn Dorney, MPH; Phone Number: 708-663-0053; Email: Jocelyn.dorney@yale.edu
• Study Contact Backup: Name: Bonnie Garmisa, MAT; Phone Number: (203) 640-2684; Email: bonnie.garmisa@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale
  • Massachusetts
    • Boston, Massachusetts, United States, 02199
      • Not yet recruiting
      • Massachusetts General Brigham Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • Houston Methodist
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Sentara Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Elevated BP, defined as an average resting BP of >=135/85 mmHg based on 3 consecutive blood pressure readings

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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. 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.	Other: 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.
Experimental: 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 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.	Other: 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.; Behavioral: 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).
No Intervention: Usual Care; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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).	6 months, 12 months, 18 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Erica Spatz, MD, Yale University; Principal Investigator: Rafael Perez-Escamilla, MD, Yale University

Publications and helpful links

Helpful Links

• Pressure Check website

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: hypertension; digital health; community health worker; remote patient monitoring
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Health Care Facilities Workforce and Services; Health Personnel; Allied Health Personnel; Community Health Workers
• Other Study ID Numbers: 2000036141; HM-2022C2-28354 (Other Grant/Funding Number: PCORI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be shared upon request.
• IPD Sharing Access Criteria: Because of the sensitive nature of the data collected in this study, investigators will require all users to enter into a data agreement that stipulates that 1) data will be used for research purposes only and will not be used to identify individual participants, 2) data will remain at Yale and a Yale analyst will run the requested data at the expense of the requestor. Under certain circumstances, we will transfer data to outside investigators after a DUA is signed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes