PRESSURE CHECK: Find Your Path to Better Health
PRESSURE CHECK
2 other identifiers
interventional
1,440
1 country
4
Brief 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 (CHW). These 2 strategies are being compared with a standard community screening program with referral to primary care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2023
CompletedFirst Posted
Study publicly available on registry
November 8, 2023
CompletedStudy Start
First participant enrolled
April 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
March 24, 2026
March 1, 2026
2.9 years
November 2, 2023
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Difference in systolic BP between study groups, measured at CBO
6 months, 12 months, 18 months
Difference in BP control by study group, measured at CBO
6 months, 12 months, 18 months
Change in Well-being
6 months, 12 months, 18 months
Change in Lifestyle behaviors
6 months, 12 months, 18 months
Study Arms (3)
Remote Blood Pressure (BP) Management Program
ACTIVE COMPARATORParticipants 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)
EXPERIMENTALParticipants 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 INTERVENTIONParticipants 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.
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- Elevated BP, defined as an average resting BP of \>=135/85 mmHg based on 3 consecutive blood pressure readings
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (4)
Yale
New Haven, Connecticut, 06520, United States
Massachusetts General Brigham Hospital
Boston, Massachusetts, 02199, United States
Houston Methodist
Houston, Texas, 77030, United States
Sentara Health
Norfolk, Virginia, 23502, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erica Spatz, MD
Yale University
- PRINCIPAL INVESTIGATOR
Rafael Perez-Escamilla, MD
Yale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2023
First Posted
November 8, 2023
Study Start
April 14, 2024
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
March 24, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be shared upon request.
- 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.
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.