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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| SBP Reduction ≥10 mmHg | Proportion of participants achieving ≥10 mmHg reduction in systolic blood pressure from baseline. | 12 weeks |
| Blood Pressure Control | Proportion of participants achieving SBP <130 mmHg at 3-month follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Lynch, PhD | Contact | 312-563-2254 | Elizabeth_Lynch@rush.edu | |
| Rebecca Dawar, MPH | Contact | 312-942-8571 | Rebecca_Dawar@rush.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Lynch, PhD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33855861 | Background | 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. | |
| 22412073 |
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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.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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|
| 12 weeks |
| Medication Adherence | Change in medication adherence measured using the ARMS questionnaire. | Baseline and 12 weeks |
| Feasibility (Recruitment and Retention) | Enrollment rate, retention rate, and completion of 3-month follow-up. | Through 12 weeks |
| Acceptability of Intervention | Study staff acceptability measured using the Acceptability of Intervention Measure (AIM). | 12 weeks |
| Patient Satisfaction | Participant satisfaction with the community-based hypertension program. | 12 weeks |
| Social Determinants of Health (SDOH) | Change in reported social needs including housing, food insecurity, transportation, and access barriers. | Baseline and 12 weeks |
| Healthcare Utilization (Exploratory) | Self-reported emergency department visits and hospitalizations. | 12 weeks |
| Primary Care Re-engagement Within 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 |
| 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. |
| 29984137 | Background | 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. |
| 30354579 | Background | 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. |
| 33677520 | Background | 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. |
| 24671049 | Background | 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. |
| 36815464 | Background | 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. |
| 24030130 | Background | 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. |
| 32495306 | Background | 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. |
| 29527973 | Background | 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. |
| 20307806 | Background | 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. |
| 27924622 | Background | 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. |
| 29380142 | Background | 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. |
| 31343960 | Background | 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. |
| 36622491 | Background | 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. |
| 31865786 | Background | 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. |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |