Establishment of Quality Control Index System and Strategy for Chronic Obstructive Pulmonary Disease in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,600
- 试验地点
- 1
- 主要终点
- rate of exacerbations of COPD (AECOPD)
研究概览
简要总结
This is a 1 year longitudinal study to establish a related index system for chronic obstructive pulmonary disease(COPD) quality control.Clinical and economic data of COPD patients will be collected and analyzed.
详细描述
Sixteen hospitals in Guangdong Province were randomly divided into control group and intervention group.Doctors and nurses of intervention group were trained treat chronic obstructive pulmonary disease according to the GOLD(Global InitiaTive of Chronic Obstructive Lung Disease) guidelines，while those in the control group will not receive any training from research team. Hospital patient cohort and outpatient cohort will be setted. Subjects were interviewed and received pulmonary function tests.All patients will be followed and events of acute exacerbation will be recorded.Factors that influence patient prognosis and economic-health benefits will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients was diagnosed as COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines older than 40 years old.Patients was hospitalized for AECOPD or visiting outpatient department for COPD.
- •A signed and dated written informed consent is obtained prior to participation.
- •Able to comply with the requirements of the protocol and be available for study visits over 1 years.
排除标准
- •A COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •Known respiratory disorders, or disorders identified at screening/visit
- •1 (including identification on the first CT scan), other than COPD (e.g.: lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis)
- •Having undergone lung surgery (e.g. lung reduction, lung transplant)
- •Severe liver and kidney dysfunction
- •Have cancer or have had cancer in the 5 years prior to study entry
- •Taking part in a blinded drug study
结局指标
主要结局
rate of exacerbations of COPD (AECOPD)
时间窗: 1 year
The rate of exacerbations within 1 year in the intervention group and the control group will be tracked.
次要结局
- change of Forced expiratory volume in one second(FEV1)(1 year)
- rate of readmission for AECOPD(1 year)
研究者
Fengyan Wang
Principal Investigator
Guangzhou Institute of Respiratory Disease