Check, Monitor, Control Hypertension in Older African American Adults (#Check, Monitor, Control)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Change in Systolic Blood Pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pharmacist Only (Control Group)
Participants receive usual hypertension care as per standard practice provided by a clinical pharmacists
干预措施: Pharmacists Only (Control Group) (Other)
Combined Intervention (Pharmacists + CHW Interventions)
Participants receive both Pharmacist and CHW Counseling and Support
干预措施: Combined Intervention (Pharmacists + CHW Interventions) (Other)
结局指标
主要结局
Change in Systolic Blood Pressure
时间窗: 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.
次要结局
- 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)
