Implementation of a Combination Intervention for Sustainable Blood Pressure Control in KwaZulu-Natal, South Africa (IMPACT-BP)
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
- 否
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)
Participants will receive clinic-based standard of care
干预措施: Standard of Care Model (Behavioral)
Community Health Worker Care Model (CHW)
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+)
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
Thomas A Gaziano
Associate Professor
Brigham and Women's Hospital
