The "Check, Monitor, Control Hypertension" Study is a 24-month Randomized Trial in Houston Targeting African Americans Aged 55+. It Combines Pharmacist Counseling and CHW Support to Improve Blood Pressure Control in Hypertension Management.

Check, Monitor, Control Hypertension in Older African American Adults (#Check, Monitor, Control)

The proposed study, "Check, Monitor, Control Hypertension in Older African American Adults," is a randomized clinical trial designed to improve blood pressure control among African American adults aged 55 years and older in the Greater Houston area. Hypertension disproportionately affects African Americans, contributing to higher rates of cardiovascular disease and stroke. This project aims to improve clinical and behavioral outcomes through a 24-month intervention combining pharmacist-led counseling and Community Health Worker (CHW) support.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Other: Pharmacists Only (Control Group); Other: Combined Intervention (Pharmacists + CHW Interventions)

Detailed Description

Hypertension (high blood pressure) is a major health concern in the United States, especially among African Americans, who experience higher rates of uncontrolled blood pressure and related complications like heart disease and stroke. This study aims to improve blood pressure control in older African American adults through a community-based approach that combines pharmacist-led counseling and Community Health Worker (CHW) support.

The study will enroll 480 African American adults aged 55 and older living in the Greater Houston area who have a history of hypertension. Participants will be randomly assigned to one of two groups: Pharmacist-only intervention - Participants receive medication therapy management and education on blood pressure monitoring and lifestyle changes; Pharmacist + CHW intervention - In addition to pharmacist counseling, participants receive personalized support from a CHW to overcome barriers like transportation and food insecurity, plus eight group health workshops each year. Both groups will receive a digital blood pressure monitor and guidance on checking blood pressure at home.

This matters because African Americans face unique challenges in managing hypertension, including contextual factors and limited access to care. By combining medical expertise with community-based support, this study hopes to empower participants to take control of their health and improve hypertension outcomes.

Timeline & Safety

Recruitment begins: January 2026 Intervention duration: 24 months Primary completion date: May 2030 The study poses minimal risk, mainly mild discomfort from blood pressure checks. Privacy will be protected using HIPAA-compliant systems, and participation is voluntary.

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ivy 0 Poon, Pharm.D., M.S., BCPS; Phone Number: 713-313-4400; Email: ivy.poon@tsu.edu
• Study Contact Backup: Name: Creaque C Tyler, PharmD, BCGP; Email: creaque.charles@tsu.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77004
      • Recruiting
      • 3100 Cleburne Street, Nabrit Science Building,
      • Contact: Ivy 0 Poon, Pharm.D., M.S., BCPS; Phone Number: 713-313-4400; Email: ivy.poon@tsu.edu
      • Contact: Creaque C Tyler, PharmD, BCGP; Email: creaque.charles@tsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Individuals are eligible to the study if they are:

• 55 years or older
• Have at least 2 high blood pressure readings ≥ 130/80 mmHg within one month
• Past Medical History of hypertension > 1 year
• Taking at least 1 antihypertensive medication
• Independent Activities of Daily Livings (ADL) and instrumental Activities of Daily Livings (iADL)
• Have a SmartPhone
• Live within the Greater Houston Metropolitan Areas
• Able to speak English

Exclusion criteria:

• Unable to verbalize comprehension of study or impaired cognitive function (e.g. dementia)
• Not able to monitor blood pressure at home
• Plans to relocate outside Houston within the next year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pharmacist Only (Control Group); Participants receive usual hypertension care as per standard practice provided by a clinical pharmacists	Other: Pharmacists Only (Control Group); Medication management and disease state counseling provided by a clinical pharmacist.
Experimental: Combined Intervention (Pharmacists + CHW Interventions); Participants receive both Pharmacist and CHW Counseling and Support	Other: Combined Intervention (Pharmacists + CHW Interventions); Participants receive CHW Individual patient assistance and group health workshops in addition to pharmacist interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic Blood Pressure	Mean change in systolic blood pressure (mmHg) from baseline to 24 months, measured using standardized BP readings.	Baseline, 6 months, 12 months, 18 months, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diastolic Blood Pressure	Mean change in diastolic BP from baseline to 24 months.	Baseline, 6 months, 12 months, 18 months, 24 months
Medication Adherence	Proportion of participants adhering to prescribed antihypertensive medications, assessed via self-report.	Baseline, 6 months, 12 months, 18 months, 24 months
Lifestyle Behavior Changes	Changes in diet, physical activity, and assessed via validated questionnaires.	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Texas Southern University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Ivy O Poon, Pharm.D., M.S., BCPS, Texas Southern University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2030

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Health Care Facilities Workforce and Services; Health Personnel; Control Groups; Pharmacists
• Other Study ID Numbers: 6310; 2U54MD007605-32 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified individual participant data (IPD) will be shared, including:

Baseline demographic and clinical characteristics Intervention adherence data Primary and secondary outcome measures (e.g., blood pressure readings, medication adherence, lifestyle behavior changes)

• IPD Sharing Time Frame: Data will be available beginning 12 months after publication of primary results and will remain accessible for at least 5 years.
• IPD Sharing Access Criteria: Researchers must submit a data use request and agree to a data use agreement. Data will be shared through an NIH-approved repository (e.g., dbGaP or similar secure platform).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No