Effectiveness of an Integrated Program for the Prevention of Rheumatic Heart Disease in Endemic Regions: a Stepped Wedge Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6,000
- 试验地点
- 2
- 主要终点
- Rheumatic heart disease
研究概览
简要总结
The overall objective of the PREVENT trial is to evaluate the effectiveness of an integrated, school-based program for the prevention of rheumatic heart disease (RHD) in regions with an endemic pattern of RHD.
We conduct a stepped wedge cluster randomized trial in randomly selected schools in Nepal and Zambia.
The intervention will be delivered at the level of the school and consists in the introduction of a dedicated school-nurse program providing health care through education about RHD, assessment, intervention, and follow-up of GABHS pharyngitis, and facilitation of secondary antibiotic prophylaxis for children with RHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 5-16 years
排除标准
- •Children / primary caregivers not providing informed consent to participate
- •Children not attending one of the selected schools
结局指标
主要结局
Rheumatic heart disease
时间窗: The endpoint will be assessed after a minimum of 1 and a maximum of 3 years after introduction of the school nurse program.
The primary outcome of the study will be the reduction in prevalence of rheumatic heart disease according to WHF criteria 2023 as assessed by systematic echocardiographic screening.
次要结局
未报告次要终点
研究者
Thomas Pilgrim
MD, MSc
Insel Gruppe AG, University Hospital Bern