NCT07413159

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
480

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
49mo left

Started Jun 2026

Longer than P75 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

First Submitted

Initial submission to the registry

February 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2030

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

February 9, 2026

Last Update Submit

April 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in Diastolic Blood Pressure

    Baseline, 6 months, 12 months, 18 months, 24 months

  • Medication Adherence

    Baseline, 6 months, 12 months, 18 months, 24 months

  • Lifestyle Behavior Changes

    Baseline, 6 months, 12 months

Study Arms (2)

Pharmacist Only (Control Group)

ACTIVE COMPARATOR

Participants receive usual hypertension care as per standard practice provided by a clinical pharmacists

Other: Pharmacists Only (Control Group)

Combined Intervention (Pharmacists + CHW Interventions)

EXPERIMENTAL

Participants receive both Pharmacist and CHW Counseling and Support

Other: Combined Intervention (Pharmacists + CHW Interventions)

Interventions

Medication management and disease state counseling provided by a clinical pharmacist.

Pharmacist Only (Control Group)

Participants receive CHW Individual patient assistance and group health workshops in addition to pharmacist interventions

Combined Intervention (Pharmacists + CHW Interventions)

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals are eligible to the study if they are:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

3100 Cleburne Street, Nabrit Science Building,

Houston, Texas, 77004, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Control GroupsPharmacists

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Ivy O Poon, Pharm.D., M.S., BCPS

    Texas Southern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivy 0 Poon, Pharm.D., M.S., BCPS

CONTACT

Creaque C Tyler, PharmD, BCGP

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study uses an interventional study model called a randomized Parallel design. Participants (n=480) will be randomly assigned to one of two intervention groups: Pharmacist-only intervention Pharmacist + Community Health Worker (CHW) intervention The allocation is randomized, and the model includes masking for outcomes assessment. The interventions are behavioral (medication therapy management, lifestyle counseling, and CHW-led workshops) rather than drug or device-based.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 17, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2030

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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)

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available beginning 12 months after publication of primary results and will remain accessible for at least 5 years.
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).

Locations