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

This study seeks to evaluate whether a community-partnered, multi-level health system strategy to manage elevated blood pressure (BP) in the community, either with a medical model of remote BP management (RBPM) alone or RBPM plus a social model with a community health worker (CHW), is more effective in controlling hypertension than standard community screening and 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, the aim of this study is to answer the research question of whether a remote blood pressure (BP) management program (RBPM, inclusive of home BP monitoring and telehealth visits with a nurse or pharmacist) 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 BP and addressing social determinants that lead to poor health outcomes, and whether either program is more effective than the other.

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 factors, as well as socioeconomic and lifestyle factors, the physical/built environment, sociocultural factors, and discriminatory policies. This study will test the hypothesis if a medical model deployed in the community in conjunction with a CHW-driven social model that offers the full continuum of care with attendance to the social determinants of health (SDoH) will be most effective in controlling and sustaining BP control.

• Study Type: Interventional
• Enrollment (Estimated): 1680
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bonnie Garmisa, MAT; Phone Number: (203) 7646964; Email: bonnie.garmisa@yale.edu
• Study Contact Backup: Name: Jocelyn Dorney, MPH; Phone Number: 708-663-0053; Email: Jocelyn.dorney@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
• 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: Crossover 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 will receive a remote BP management program (RBPM) inclusive of home BP monitoring and telehealth visits with a nurse or pharmacist.	Other: Remote Blood Pressure (BP) Management Program (RBPM); Participants will receive a medical model of remote BP management (RBPM).
Experimental: Remote Blood Pressure (BP) Management Program + Community Health Worker (CHW); Participants will receive 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.	Other: Remote Blood Pressure (BP) Management Program (RBPM); Participants will receive a medical model of remote BP management (RBPM).; Behavioral: Community Health Worker (CHW); Participants will receive the additional support of a Community Health Worker (CHW).
No Intervention: Usual Care; Participants will be monitored prior to any RBPM intervention.

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, participants will be assessed 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 School of Medicine; Principal Investigator: Rafael Perez-Escamilla, MD, Yale School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

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): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No