PRESSURE CHECK: Find Your Path to Better Health

Blood Pressure Clinical Trial

— PRESSURE CHECK  

Official title:

PRESSURE CHECK: Find Your Path to Better Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06122246
• Other study ID #: 2000036141
• Secondary ID: HM-2022C2-28354
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2024
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: Bonnie Garmisa, MAT
• Phone: (203) 7646964
• Email: bonnie.garmisa[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1680
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Behavioral:
• Community Health Worker (CHW)
Participants will receive the additional support of a Community Health Worker (CHW).

Other:
• Remote Blood Pressure (BP) Management Program (RBPM)
Participants will receive a medical model of remote BP management (RBPM).

Locations

Country	Name	City	State
United States	Massachusetts General Brigham Hospital	Boston	Massachusetts
United States	Houston Methodist	Houston	Texas
United States	Yale	New Haven	Connecticut
United States	Sentara Health	Norfolk	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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