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NCT Number: NCT07547345

Mobilizing Community Hypertension Access 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community-Based Multidisciplinary Hypertension Management Program

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. SBP Reduction ≥10 mmHg

    Time frame: 12 weeks

    Proportion of participants achieving ≥10 mmHg reduction in systolic blood pressure from baseline.

  2. Blood Pressure Control

    Time frame: 12 weeks

    Proportion of participants achieving SBP <130 mmHg at 3-month follow-up.

  3. Medication Adherence

    Time frame: Baseline and 12 weeks

    Change in medication adherence measured using the ARMS questionnaire.

  4. Feasibility (Recruitment and Retention)

    Time frame: Through 12 weeks

    Enrollment rate, retention rate, and completion of 3-month follow-up.

  5. Acceptability of Intervention

    Time frame: 12 weeks

    Study staff acceptability measured using the Acceptability of Intervention Measure (AIM).

  6. Patient Satisfaction

    Time frame: 12 weeks

    Participant satisfaction with the community-based hypertension program.

  7. Social Determinants of Health (SDOH)

    Time frame: Baseline and 12 weeks

    Change in reported social needs including housing, food insecurity, transportation, and access barriers.

  8. Healthcare Utilization (Exploratory)

    Time frame: 12 weeks

    Self-reported emergency department visits and hospitalizations.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Lynch, PhD

CONTACT

[email protected]

312-563-2254

Rebecca Dawar, MPH

CONTACT

[email protected]

312-942-8571

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

Live Healthy Chicago - Community Pilot

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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