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.

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Pharmacists Only (Control Group)
  Medication management and disease state counseling provided by a clinical pharmacist.
• Другое Combined Intervention (Pharmacists + CHW Interventions)
  Participants receive CHW Individual patient assistance and group health workshops in addition to pharmacist interventions

Первичные конечные точки

• Change in Systolic Blood Pressure [Срок оценки: Baseline, 6 months, 12 months, 18 months, 24 months]

Вторичные конечные точки (3)

• Change in Diastolic Blood Pressure [Срок оценки: Baseline, 6 months, 12 months, 18 months, 24 months]
• Medication Adherence [Срок оценки: Baseline, 6 months, 12 months, 18 months, 24 months]
• Lifestyle Behavior Changes [Срок оценки: Baseline, 6 months, 12 months]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• 3100 Cleburne Street, Nabrit Science Building, — Houston

Идентификаторы

NCT: NCT07413159 · 6310 · 2U54MD007605-32

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗