Mobilizing Community Hypertension Access Pilot

April 17, 2026 updated by: Elizabeth Lynch, Rush University Medical Center

Live Healthy Chicago - Community Pilot

The Live Healthy Chicago (LHC) Community Pilot is a prospective, community-based study evaluating the feasibility, effectiveness, and economic impact of a pharmacist-led hypertension management program delivered in trusted community settings on the West and South Sides of Chicago. Adults with uncontrolled hypertension will be identified and enrolled through community-based organizations, where a mobile clinical team-including community health workers, a pharmacist, and a registered nurse-will provide blood pressure screening, medication management, health education, and care coordination over a 3-month period. The study will assess participant engagement and acceptability, changes in systolic blood pressure. This pilot aims to address disparities in hypertension control by improving access to care in underserved communities and informing scalable, community-based models of chronic disease management.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Uncontrolled hypertension is a leading contributor to cardiovascular disease and preventable morbidity and mortality in the United States, with disproportionate burden among underserved populations. In Chicago, structural inequities, limited access to primary care, and mistrust in healthcare systems contribute to significant disparities in hypertension control, particularly among Black residents on the West and South Sides. Community-based care delivery models have demonstrated success in improving blood pressure outcomes by engaging individuals in trusted, non-traditional healthcare settings.

The Live Healthy Chicago (LHC) Community Pilot is a prospective, community-based pilot study designed to evaluate the feasibility, effectiveness, and economic impact of a pharmacist-led hypertension management intervention embedded within community-based organizations. The study will enroll approximately 200 adults with uncontrolled hypertension identified through community health worker (CHW)-led screening and outreach efforts at participating sites, including churches and organizations providing social services.

Participants will receive a 3-month intervention delivered by a mobile clinical team consisting of CHWs, a pharmacist, and a registered nurse (RN). CHWs will conduct outreach, facilitate recruitment, provide health education, and support care navigation. RNs will collect baseline clinical data, provide counseling, support medication adherence, and conduct follow-up assessments. Pharmacists will perform medication reconciliation and manage antihypertensive therapy, including initiation and titration of medications under a collaborative practice agreement with supervising physicians.

Participants will be followed for 12 weeks, with regular in-person or telehealth visits to monitor blood pressure, assess medication adherence, and address social determinants of health. Home blood pressure monitoring will be encouraged, and participants may be provided with blood pressure cuffs when available. Data collection will occur at baseline and at 3-month follow-up and will include blood pressure measurements, medication adherence (via validated questionnaires), medical history, social determinants of health, and participant-reported outcomes such as satisfaction and intervention acceptability.

The primary effectiveness outcome is change in systolic blood pressure over the 3-month intervention period, including the proportion of participants achieving a clinically meaningful reduction (≥10 mmHg). Feasibility and acceptability outcomes include recruitment, retention, and participant satisfaction. Economic analyses will estimate the cost per participant and model potential cost savings associated with reduced healthcare utilization, including emergency department visits and hospitalizations.

This pilot study aims to generate preliminary evidence to support scalable, community-based hypertension care models that improve access, reduce disparities, and enhance chronic disease management in underserved urban populations.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • Elizabeth Lynch, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults 18 years or older
  • Record of two blood pressure readings of SBP>130 on two separate occasions (days) within the past 3 months

Exclusion Criteria:

  • Person is receiving dialysis
  • Person has had a heart or kidney transplant
  • Person is pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Live Healthy Chicago Intervention
Participants receive a 12-week community-based hypertension management intervention delivered by a mobile clinical team including community health workers, registered nurses, and pharmacists. The intervention includes blood pressure monitoring, medication management under a collaborative practice agreement with a physician, health education, social needs screening, and care coordination.
Behavioral: Community-Based Multidisciplinary Hypertension Management Program
A 12-week community-based hypertension management intervention delivered in community settings. The program includes pharmacist-led medication management under collaborative practice agreement, RN-led clinical monitoring and follow-up, and CHW-led outreach, education, and care navigation. Participants receive blood pressure screening, medication titration when indicated, home blood pressure monitoring support, and linkage to primary care and social services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Systolic Blood Pressure (SBP)
Time Frame: Baseline to 3 months (12 weeks)
Mean change in systolic blood pressure from baseline to 12-week follow-up among participants enrolled in the LHC intervention.
Baseline to 3 months (12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SBP Reduction ≥10 mmHg
Time Frame: 12 weeks
Proportion of participants achieving ≥10 mmHg reduction in systolic blood pressure from baseline.
12 weeks
Blood Pressure Control
Time Frame: 12 weeks
Proportion of participants achieving SBP <130 mmHg at 3-month follow-up.
12 weeks
Medication Adherence
Time Frame: Baseline and 12 weeks
Change in medication adherence measured using the ARMS questionnaire.
Baseline and 12 weeks
Feasibility (Recruitment and Retention)
Time Frame: Through 12 weeks
Enrollment rate, retention rate, and completion of 3-month follow-up.
Through 12 weeks
Acceptability of Intervention
Time Frame: 12 weeks
Study staff acceptability measured using the Acceptability of Intervention Measure (AIM).
12 weeks
Patient Satisfaction
Time Frame: 12 weeks
Participant satisfaction with the community-based hypertension program.
12 weeks
Social Determinants of Health (SDOH)
Time Frame: Baseline and 12 weeks
Change in reported social needs including housing, food insecurity, transportation, and access barriers.
Baseline and 12 weeks
Healthcare Utilization (Exploratory)
Time Frame: 12 weeks
Self-reported emergency department visits and hospitalizations.
12 weeks
Primary Care Re-engagement Within 9 Months Post-Intervention
Time Frame: 9 months post-intervention
Proportion of participants with at least one primary care visit within 9 months after the mobile intervention ends.
9 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Investigators

  • Principal Investigator: Elizabeth Lynch, PhD, Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25061903-IRB01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be made publicly available. Data collected for this study will be used for analysis and reporting in aggregate form only.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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