Rush University Medical Center
Chicago, Illinois, 60612, United States
Location status: Recruiting
Location contact
Elizabeth Lynch, PhD
CONTACT
Elizabeth Lynch, PhD
PRINCIPAL_INVESTIGATOR
Rebecca Dawar, MPH
CONTACT
NCT Number: NCT07547345
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60612, United States
Location status: Recruiting
Elizabeth Lynch, PhD
CONTACT
Elizabeth Lynch, PhD
PRINCIPAL_INVESTIGATOR
Rebecca Dawar, MPH
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 12 weeks
Proportion of participants achieving ≥10 mmHg reduction in systolic blood pressure from baseline.
Time frame: 12 weeks
Proportion of participants achieving SBP <130 mmHg at 3-month follow-up.
Time frame: Baseline and 12 weeks
Change in medication adherence measured using the ARMS questionnaire.
Time frame: Through 12 weeks
Enrollment rate, retention rate, and completion of 3-month follow-up.
Time frame: 12 weeks
Study staff acceptability measured using the Acceptability of Intervention Measure (AIM).
Time frame: 12 weeks
Participant satisfaction with the community-based hypertension program.
Time frame: Baseline and 12 weeks
Change in reported social needs including housing, food insecurity, transportation, and access barriers.
Time frame: 12 weeks
Self-reported emergency department visits and hospitalizations.
Time frame: 9 months post-intervention
Proportion of participants with at least one primary care visit within 9 months after the mobile intervention ends.
Contact information is provided by the study sponsor or research team.
Elizabeth Lynch, PhD
CONTACT
Rebecca Dawar, MPH
CONTACT
Rush University Medical Center
Other
Live Healthy Chicago - Community Pilot
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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