Community Health Worker Led Hypertension Prevention and Control (CHPC) in Nepal: An Implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,572
- 试验地点
- 1
- 主要终点
- Reach
研究概览
简要总结
The goal of this hybrid type III study incorporating a cluster-randomized trial is to assess the effect of a community health worker-led hypertension prevention and control program (CHPC) on the implementation outcomes and clinical outcomes among patient with hypertension in central Nepal. The main questions it aims to answer are:
1. What is the level of implementation outcomes, including reach, adoption, implementation fidelity, and maintenance of the CHPC implementation strategy at the patient, provider, and health system levels?
2: What is the effectiveness of the CHPC implementation strategy compared to facility-based intervention on systolic BP via a cluster randomized controlled trial.
3: What is the implementation cost and cost-effectiveness of the CHPC implementation strategy?
Participants will receive four follow-up group meetings or home visits every three months for a year by a community health worker. Researchers will compare if there is a significant difference in systolic blood pressure between those who receive this intervention and those who do not receive the intervention in the same community.
详细描述
INTRODUCTION:
Hypertension (HTN) is a global public health challenge. About 13.5% of global total mortality is attributed to high blood pressure (BP) worldwide. In addition, about 54% of strokes and 47% of coronary heart disease worldwide were attributable to high BP. In Nepal, the adult HTN prevalence is 25%, similar to the global prevalence. Community Health Workers (CHWs) are the frontline pillars of community-based health programs in Nepal. Through CHW, this investigation aims to influence HTN control and behavior change among adults and society at large. By providing a replicable model for increasing HTN awareness, treatment, and control in Nepal, investigators will accelerate the integration of effective intervention into practice, providing an example of amelioration of the well-documented delays in moving tested interventions to practice. To ensure relevance to policymakers, the investigators will follow the principles of 'practical trials that include: (a) implementing the strategy, (b) facilitating and evaluating the maintenance of the strategy beyond the implementation phase; (c) using multiple evaluation measures relevant to decision makers, including reach, adoption, and cost; and (d) evaluating effectiveness across multiple outcomes, with a plan to triangulate findings from across multiple data sources using both qualitative and quantitative measures.
METHODS:
Investigators will conduct a Hybrid type III effectiveness-implementation design focusing primarily on implementation outcomes while also collecting effectiveness outcomes as they relate to the uptake or fidelity of the intervention. The primary implementation outcomes (aim 1) - reach, adoption, implementation and maintenance - are selected to answer the central research question of this study and will be assessed using a non-inferiority design. Investigators will assess these outcomes in the intervention group using data from the process evaluation in intervention health facilities. For each outcome, the null hypothesis is that the percentages are equivalent to a set target or greater. Thus, if the program is successful, investigators will be able to say with 95% confidence that these high standards have been met. To measure the effectiveness (aim 2), investigators will use a cluster-randomized design to assess change in mean systolic BP in the intervention group compared to the control group at 12 months after the intervention. Investigators will also measure cost and estimate incremental cost per participant with awareness on and control of high BP (aim 3).
STUDY SETTING:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High blood pressure (BP) of 140/90 mmHg or higher.
排除标准
- •Severe illness requiring bed rest
- •Pregnant women, due to their special health needs
研究组 & 干预措施
Control Group
Usual care that includes patients visit to health facility based on felt need
Intervention arm
Community Health Worker Intervention
干预措施: Community Health Worker Intervention (Behavioral)
结局指标
主要结局
Reach
时间窗: 12 months
Percentage of CHWs implementing the program
Adoption
时间窗: 12 months
Percentage of the health facilities asked to participate in adopting the program
Program implementation
时间窗: 12 months
Percent of the health facility will implement a minimum standard to program implementation
Maintenance
时间窗: 24 months
Percentage of the health facility that will implement a minimum standard to program implementation during the maintenance period
次要结局
- Blood Pressure(12 months)
- Hypertension Diagnosis Awareness(12 months)
- Blood Pressure Control(12 months)
- Physical activity(12 months)
- Fruits and Vegetables(12 months)
- Medication(12 months)
- Affordability(12 months)
- Equity(12 months)
- Scalability(12 months)
- Cost-effectiveness(12 months)