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临床试验/NCT07413159
NCT07413159招募中不适用

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

Texas Southern University1 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

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

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)

Active Comparator

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)

Experimental

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)

研究者

发起方
Texas Southern University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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