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.

April 8, 2026 updated by: Texas Southern University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
480

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ivy 0 Poon, Pharm.D., M.S., BCPS
  • Phone Number: 713-313-4400
  • Email: ivy.poon@tsu.edu

Study Contact Backup

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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Systolic Blood Pressure
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Diastolic Blood Pressure
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
Mean change in diastolic BP from baseline to 24 months.
Baseline, 6 months, 12 months, 18 months, 24 months
Medication Adherence
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
Proportion of participants adhering to prescribed antihypertensive medications, assessed via self-report.
Baseline, 6 months, 12 months, 18 months, 24 months
Lifestyle Behavior Changes
Time Frame: Baseline, 6 months, 12 months
Changes in diet, physical activity, and assessed via validated questionnaires.
Baseline, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Southern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ivy O Poon, Pharm.D., M.S., BCPS, Texas Southern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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