Epidemiological Status and Intervention Technologies for COPD and Pulmonary Tuberculosis Comorbidity in Primary Care Settings in Henan Province, China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25,000
- 主要终点
- The prevalence of bacteriologically confirmed PTB
研究概览
简要总结
The goal of this trial is to evaluate the effectiveness of an active case-finding (ACF) strategy for detecting pulmonary tuberculosis (PTB) among patients with chronic obstructive pulmonary disease (COPD) in primary care settings in Henan Province, China. It will also assess the epidemiological status of COPD-PTB comorbidity in this population and evaluate the feasibility of the ACF strategy in real-world primary care settings.
This is a stepped-wedge cluster randomized controlled trial. Specifically, the intervention group will receive the ACF strategy in Year 1, Year 2, and Year 3, while the control group will receive routine follow-up care in Year 1 and Year 2, and will transition to receive the ACF intervention in Year 3. All clusters will eventually receive the ACF intervention.
The main questions it aims to answer are:
Does the ACF strategy decrease the prevalence of PTB among COPD patients compared with routine passive case-finding? What are the current prevalence and epidemiological characteristics of COPD-PTB comorbidity in primary care settings in Henan Province?
Participants will:
Receive ACF screening during their routine COPD follow-up visits in the intervention phase.
Continue their usual COPD care as prescribed by their healthcare providers. If diagnosed with PTB through ACF screening, participants will be referred to designated hospitals for treatment in accordance with the national standardized tuberculosis treatment protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 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
- •aged 18 years or older;
- •residence in the local area for at least six months;
- •providing written informed consent to participate in the study.
排除标准
- •inability to provide informed consent or complete the questionnaire;
- •contraindications to CT scanning;
- •current pregnancy.
结局指标
主要结局
The prevalence of bacteriologically confirmed PTB
时间窗: the third year
次要结局
- Diagnosis delay time(Up to 36 months)
