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临床试验/NCT05492955
NCT05492955已完成不适用

Implementation of a Combination Intervention for Sustainable Blood Pressure Control in KwaZulu-Natal, South Africa (IMPACT-BP)

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 774 人开始时间: 2022年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
774
试验地点
1
主要终点
Mean Systolic Blood Pressure (SBP) Change

研究概览

简要总结

This is a randomized clinical trial intended to identify the optimal strategy of blood pressure management in rural South Africa using Community Health Workers (CHWs) in conjunction with in-home BP monitoring among adults.

详细描述

We will conduct a trial using CHWs in conjunction with in-home BP monitoring among 774 adults ≥ 18 years old residing in uMkhanyakude District in northern KwaZulu-Natal in an area that is served by a CHW. Eligible participants will be recruited from prior community-based hypertension screening programs, CHW-led hypertension screening activities, and/or from trial clinics where they are accessing care. Consenting participants will be randomized to one of the three study arms of hypertension care (258 participants per arm): 1) clinic-based standard of care model (SOC); 2) community health worker-based blood pressure monitoring model (CHW); 3) and enhanced community health worker-based model, including mobile health blood pressure monitoring model (eCHW+). Independent of clinical care, all participants will be seen at enrollment and at 6 months for BP monitoring and data collection by study nurses for outcome assessments. The primary effectiveness outcome will be assessed in an intention-to-treat analysis and defined as the change in systolic blood pressure (SBP) 6 months after enrollment. The secondary effectiveness outcome will be the proportion of participants with controlled blood pressure, as defined by an SBP <140 mmHg and a diastolic BP (DBP) <90 mmHg 6 months after enrollment.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than 18 years old
  • Residing in uMkhanyakude District in northern KwaZulu-Natal in an area that is served by a CHW.
  • Elevated blood pressure (blood pressure > 140/90 mmHg) on two measurements.

排除标准

  • Pregnant or breast-feeding women.
  • Severe, symptomatic hypertension with a measured blood pressure > 180/110 mmHg.
  • Known, advanced chronic kidney disease. GFR < 60 ml/min/1.73 m
  • Current use of at least 3 different anti-hypertensive therapies at full dose.
  • Planning to move within the next 24 months.

研究组 & 干预措施

Standard of Care (SOC)

Active Comparator

Participants will receive clinic-based standard of care

干预措施: Standard of Care Model (Behavioral)

Community Health Worker Care Model (CHW)

Experimental

Participants will be given a standard blood pressure cuff (Omron) for at-home BP monitoring, and will be assigned to a CHW for follow-up visits and medication delivery.

干预措施: Community Health Worker Care Model (Behavioral)

Enhanced Community Health Worker + Mobile Health Monitoring (eCHW+)

Experimental

Participants will be given a blood pressure cuff with cellular capability (Blipcare) for at-home BP monitoring which automatically transmit BP data to our server for nurse review. These participants will also be assigned to a CHW for follow-up visits and medication delivery.

干预措施: Enhanced Community Health Worker-based with Mobile Health Blood Pressure Monitoring Model (Behavioral)

结局指标

主要结局

Mean Systolic Blood Pressure (SBP) Change

时间窗: 6 months

Absolute change in systolic blood pressure (SBP) between baseline and 6 months after enrollment.

次要结局

  • Percentage of Participants With Blood Pressure Control (%)(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas A Gaziano

Associate Professor

Brigham and Women's Hospital

研究点 (1)

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