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Mobilizing Community Hypertension Access Pilot

Live Healthy Chicago - Community Pilot

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07547345
Enrollment
200
Registered
2026-04-23
Start date
2026-02-20
Completion date
2027-03-01
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Blood Pressure Control, Cardiovascular Disease Prevention, Pharmacist-Led Care, Community-Based Intervention, Community Health Workers, Mobile Health Services, Medication Management, Medication Adherence, Health Disparities, Underserved Populations, Social Determinants of Health, Care Coordination, Chronic Disease Management, Preventive Cardiology, Urban Health, Feasibility Study, Pilot Study, Cost-Effectiveness, Population Health

Brief summary

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.

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.

Interventions

BEHAVIORALCommunity-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.

Sponsors

Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Systolic Blood Pressure (SBP)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.

Secondary

MeasureTime frameDescription
SBP Reduction ≥10 mmHg12 weeksProportion of participants achieving ≥10 mmHg reduction in systolic blood pressure from baseline.
Blood Pressure Control12 weeksProportion of participants achieving SBP \<130 mmHg at 3-month follow-up.
Medication AdherenceBaseline and 12 weeksChange in medication adherence measured using the ARMS questionnaire.
Feasibility (Recruitment and Retention)Through 12 weeksEnrollment rate, retention rate, and completion of 3-month follow-up.
Acceptability of Intervention12 weeksStudy staff acceptability measured using the Acceptability of Intervention Measure (AIM).
Patient Satisfaction12 weeksParticipant satisfaction with the community-based hypertension program.
Social Determinants of Health (SDOH)Baseline and 12 weeksChange in reported social needs including housing, food insecurity, transportation, and access barriers.
Healthcare Utilization (Exploratory)12 weeksSelf-reported emergency department visits and hospitalizations.
Primary Care Re-engagement Within 9 Months Post-Intervention9 months post-interventionProportion of participants with at least one primary care visit within 9 months after the mobile intervention ends.

Countries

United States

Contacts

CONTACTElizabeth Lynch, PhD
Elizabeth_Lynch@rush.edu312-563-2254
CONTACTRebecca Dawar, MPH
Rebecca_Dawar@rush.edu312-942-8571
PRINCIPAL_INVESTIGATORElizabeth Lynch, PhD

Rush University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026