Hypertension
Conditions
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.
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.
Interventions
Medication management and disease state counseling provided by a clinical pharmacist.
Participants receive CHW Individual patient assistance and group health workshops in addition to pharmacist interventions
Sponsors
Study design
Intervention model description
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.
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diastolic Blood Pressure | Baseline, 6 months, 12 months, 18 months, 24 months | Mean change in diastolic BP from baseline to 24 months. |
| Medication Adherence | Baseline, 6 months, 12 months, 18 months, 24 months | Proportion of participants adhering to prescribed antihypertensive medications, assessed via self-report. |
| Lifestyle Behavior Changes | Baseline, 6 months, 12 months | Changes in diet, physical activity, and assessed via validated questionnaires. |
Countries
United States
Contacts
Texas Southern University