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HypertensionNCT07547345

Mobilizing Community Hypertension Access Pilot

A study testing Community-Based Multidisciplinary Hypertension Management Program in people with Hypertension, run by Rush University Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
Community-Based Multidisciplinary Hypertension Management Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
20 Feb 2026to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elizabeth Lynch, PhD contact

312-563-2254

Elizabeth_Lynch@rush.edu

Rebecca Dawar, MPH contact

312-942-8571

Rebecca_Dawar@rush.edu

United States1 site, 1 recruiting
  • Rush University Medical Center

    Chicago, Illinois, 60612

    Elizabeth Lynch, PhD, 312-563-2254, Elizabeth_Lynch@rush.edu

    Rebecca Dawar, MPH, 312-942-8571, Rebecca_Dawar@rush.edu

    Recruiting

Other trials in United States

About this study

Official title: Live Healthy Chicago - Community 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.

Read the 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.

Conditions
Hypertension
Being tested
Community-Based Multidisciplinary Hypertension Management Program
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
Medical subject headings
Hypertension, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community-Based Multidisciplinary Hypertension Management ProgramBehavioural

    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.

Study groups in NCT07547345
Study groupRoleWhat they receive
Live Healthy Chicago InterventionExperimentalParticipants 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.
Receives: Behavioral: Community-Based Multidisciplinary Hypertension Management Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 3 months (12 weeks)

Secondary outcomes (9)
  1. SBP Reduction ≥10 mmHg

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

    Measured: 12 weeks

  2. Blood Pressure Control

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

    Measured: 12 weeks

  3. Medication Adherence

    Change in medication adherence measured using the ARMS questionnaire.

    Measured: Baseline and 12 weeks

  4. Feasibility (Recruitment and Retention)

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

    Measured: Through 12 weeks

  5. Acceptability of Intervention

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

    Measured: 12 weeks

  6. Patient Satisfaction

    Participant satisfaction with the community-based hypertension program.

    Measured: 12 weeks

  7. Social Determinants of Health (SDOH)

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

    Measured: Baseline and 12 weeks

  8. Healthcare Utilization (Exploratory)

    Self-reported emergency department visits and hospitalizations.

    Measured: 12 weeks

  9. 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.

    Measured: 9 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study start20 Feb 2026
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07547345
Sponsor's protocol ID
25061903-IRB01
Status last verified
Apr 2026
First submitted
1 Apr 2026
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 33855861
  • 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.

    PubMed 22412073
  • 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.

    PubMed 29984137
  • 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.

    PubMed 30354579
  • 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.

    PubMed 33677520
  • 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.

    PubMed 24671049
  • 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.

    PubMed 36815464
  • 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.

    PubMed 24030130
  • 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.

    PubMed 32495306
  • 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.

    PubMed 29527973
  • 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.

    PubMed 20307806
  • 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.

    PubMed 27924622
  • 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.

    PubMed 29380142
  • 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.

    PubMed 31343960
  • 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.

    PubMed 36622491

Questions about this trial

What is this clinical trial studying?

A study testing Community-Based Multidisciplinary Hypertension Management Program in people with Hypertension, run by Rush University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elizabeth Lynch, PhD (312-563-2254, Elizabeth_Lynch@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Systolic Blood Pressure (SBP) (time frame: Baseline to 3 months (12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07547345, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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