NCT07547345

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
9mo left

Started Feb 2026

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Feb 2026Mar 2027

Study Start

First participant enrolled

February 20, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 1, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 1, 2026

Last Update Submit

April 17, 2026

Conditions

Keywords

HypertensionBlood Pressure ControlCardiovascular Disease PreventionPharmacist-Led CareCommunity-Based InterventionCommunity Health WorkersMobile Health ServicesMedication ManagementMedication AdherenceHealth DisparitiesUnderserved PopulationsSocial Determinants of HealthCare CoordinationChronic Disease ManagementPreventive CardiologyUrban HealthFeasibility StudyPilot StudyCost-EffectivenessPopulation Health

Outcome Measures

Primary Outcomes (1)

  • Change in Systolic Blood Pressure (SBP)

    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 Outcomes (9)

  • SBP Reduction ≥10 mmHg

    12 weeks

  • Blood Pressure Control

    12 weeks

  • Medication Adherence

    Baseline and 12 weeks

  • Feasibility (Recruitment and Retention)

    Through 12 weeks

  • Acceptability of Intervention

    12 weeks

  • +4 more secondary outcomes

Study Arms (1)

Live Healthy Chicago Intervention

EXPERIMENTAL

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

Interventions

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.

Live Healthy Chicago Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (16)

  • Bryant KB, Moran AE, Kazi DS, Zhang Y, Penko J, Ruiz-Negron N, Coxson P, Blyler CA, Lynch K, Cohen LP, Tajeu GS, Fontil V, Moy NB, Ebinger JE, Rader F, Bibbins-Domingo K, Bellows BK. Cost-Effectiveness of Hypertension Treatment by Pharmacists in Black Barbershops. Circulation. 2021 Jun 15;143(24):2384-2394. doi: 10.1161/CIRCULATIONAHA.120.051683. Epub 2021 Apr 15.

    PMID: 33855861BACKGROUND
  • Bennett GG, Warner ET, Glasgow RE, Askew S, Goldman J, Ritzwoller DP, Emmons KM, Rosner BA, Colditz GA; Be Fit, Be Well Study Investigators. Obesity treatment for socioeconomically disadvantaged patients in primary care practice. Arch Intern Med. 2012 Apr 9;172(7):565-74. doi: 10.1001/archinternmed.2012.1. Epub 2012 Mar 12.

    PMID: 22412073BACKGROUND
  • Ursua RA, Aguilar DE, Wyatt LC, Trinh-Shevrin C, Gamboa L, Valdellon P, Perrella EG, Dimaporo MZ, Nur PQ, Tandon SD, Islam NS. A community health worker intervention to improve blood pressure among Filipino Americans with hypertension: A randomized controlled trial. Prev Med Rep. 2018 May 9;11:42-48. doi: 10.1016/j.pmedr.2018.05.002. eCollection 2018 Sep.

    PMID: 29984137BACKGROUND
  • Schoenthaler AM, Lancaster KJ, Chaplin W, Butler M, Forsyth J, Ogedegbe G. Cluster Randomized Clinical Trial of FAITH (Faith-Based Approaches in the Treatment of Hypertension) in Blacks. Circ Cardiovasc Qual Outcomes. 2018 Oct;11(10):e004691. doi: 10.1161/CIRCOUTCOMES.118.004691.

    PMID: 30354579BACKGROUND
  • Kaholokula JK, Look M, Mabellos T, Ahn HJ, Choi SY, Sinclair KA, Wills TA, Seto TB, de Silva M. A Cultural Dance Program Improves Hypertension Control and Cardiovascular Disease Risk in Native Hawaiians: A Randomized Controlled Trial. Ann Behav Med. 2021 Oct 4;55(10):1006-1018. doi: 10.1093/abm/kaaa127.

    PMID: 33677520BACKGROUND
  • Kim KB, Han HR, Huh B, Nguyen T, Lee H, Kim MT. The effect of a community-based self-help multimodal behavioral intervention in Korean American seniors with high blood pressure. Am J Hypertens. 2014 Sep;27(9):1199-208. doi: 10.1093/ajh/hpu041. Epub 2014 Mar 26.

    PMID: 24671049BACKGROUND
  • Islam NS, Wyatt LC, Ali SH, Zanowiak JM, Mohaimin S, Goldfeld K, Lopez P, Kumar R, Beane S, Thorpe LE, Trinh-Shevrin C. Integrating Community Health Workers into Community-Based Primary Care Practice Settings to Improve Blood Pressure Control Among South Asian Immigrants in New York City: Results from a Randomized Control Trial. Circ Cardiovasc Qual Outcomes. 2023 Mar;16(3):e009321. doi: 10.1161/CIRCOUTCOMES.122.009321. Epub 2023 Feb 23.

    PMID: 36815464BACKGROUND
  • Svarstad BL, Kotchen JM, Shireman TI, Brown RL, Crawford SY, Mount JK, Palmer PA, Vivian EM, Wilson DA. Improving refill adherence and hypertension control in black patients: Wisconsin TEAM trial. J Am Pharm Assoc (2003). 2013 Sep-Oct;53(5):520-9. doi: 10.1331/JAPhA.2013.12246.

    PMID: 24030130BACKGROUND
  • Ma GX, Bhimla A, Zhu L, Beeber M, Aczon F, Tan Y, Quinn SB, Khan O, Gadegbeku CA. Development of an Intervention to Promote Physical Activity and Reduce Dietary Sodium Intake for Preventing Hypertension and Chronic Disease in Filipino Americans. J Racial Ethn Health Disparities. 2021 Apr;8(2):283-292. doi: 10.1007/s40615-020-00781-z. Epub 2020 Jun 3.

    PMID: 32495306BACKGROUND
  • Victor RG, Lynch K, Li N, Blyler C, Muhammad E, Handler J, Brettler J, Rashid M, Hsu B, Foxx-Drew D, Moy N, Reid AE, Elashoff RM. A Cluster-Randomized Trial of Blood-Pressure Reduction in Black Barbershops. N Engl J Med. 2018 Apr 5;378(14):1291-1301. doi: 10.1056/NEJMoa1717250. Epub 2018 Mar 12.

    PMID: 29527973BACKGROUND
  • O'Neil SS, Lake T, Merrill A, Wilson A, Mann DA, Bartnyska LM. Racial disparities in hospitalizations for ambulatory care-sensitive conditions. Am J Prev Med. 2010 Apr;38(4):381-8. doi: 10.1016/j.amepre.2009.12.026.

    PMID: 20307806BACKGROUND
  • Doshi RP, Aseltine RH Jr, Sabina AB, Graham GN. Racial and Ethnic Disparities in Preventable Hospitalizations for Chronic Disease: Prevalence and Risk Factors. J Racial Ethn Health Disparities. 2017 Dec;4(6):1100-1106. doi: 10.1007/s40615-016-0315-z. Epub 2016 Dec 6.

    PMID: 27924622BACKGROUND
  • Josiah Willock R, Miller JB, Mohyi M, Abuzaanona A, Muminovic M, Levy PD. Therapeutic Inertia and Treatment Intensification. Curr Hypertens Rep. 2018 Jan 29;20(1):4. doi: 10.1007/s11906-018-0802-1.

    PMID: 29380142BACKGROUND
  • Powell W, Richmond J, Mohottige D, Yen I, Joslyn A, Corbie-Smith G. Medical Mistrust, Racism, and Delays in Preventive Health Screening Among African-American Men. Behav Med. 2019 Apr-Jun;45(2):102-117. doi: 10.1080/08964289.2019.1585327.

    PMID: 31343960BACKGROUND
  • Abrahamowicz AA, Ebinger J, Whelton SP, Commodore-Mensah Y, Yang E. Racial and Ethnic Disparities in Hypertension: Barriers and Opportunities to Improve Blood Pressure Control. Curr Cardiol Rep. 2023 Jan;25(1):17-27. doi: 10.1007/s11886-022-01826-x. Epub 2023 Jan 9.

    PMID: 36622491BACKGROUND
  • Fuchs FD, Whelton PK. High Blood Pressure and Cardiovascular Disease. Hypertension. 2020 Feb;75(2):285-292. doi: 10.1161/HYPERTENSIONAHA.119.14240. Epub 2019 Dec 23.

    PMID: 31865786BACKGROUND

MeSH Terms

Conditions

HypertensionMedication Adherence

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Elizabeth Lynch, PhD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Lynch, PhD

CONTACT

Rebecca Dawar, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Family and Preventive Medicine

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 23, 2026

Study Start

February 20, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations