REspiratory diSEAse cohoRt Studies of CHinese Medicine for CAP (RESEARCH- CAP)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,078
- 主要终点
- Rehospitalization rate
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy and safety of dialectical treatment in the patients with CAP after discharge in a prospective cohort study: one is the Traditional Chinese Medicine (TCM) cohort, which has been evaluated and has certain effects; The other is a non traditional Chinese medicine queue.
详细描述
Community acquired pneumonia (CAP) has a high incidence rate, hospitalization rate, case fatality rate and heavy disease burden. The follow-up and post discharge intervention for CAP patients are weak, and they face the risk of re hospitalization or even death due to recurrent pneumonia or other reasons. In clinical practice, more attention has been paid to the improvement of clinical symptoms during hospitalization for patients with CAP, and there is a lack of reports on continued intervention outside the hospital to reduce readmission rates. Therefore, it is necessary to conduct cohort studies on CAP.
This is a multicenter, prospective cohort study aimed at evaluating the clinical efficacy and safety of dialectical treatment for CAP patients. This cohort study will recruit approximately 1078 patients, divided into two cohorts: one is a traditional Chinese medicine cohort, and these patients have been evaluated and have shown certain effectiveness; Another non traditional Chinese medicine cohort, where participants from both cohorts will receive a one-year follow-up period. The main outcome measure is readmission rate. Secondary efficacy indicators include efficacy satisfaction, physician reported outcomes, patient reported outcomes, quality of life ，nutritional status, Acute upper respiratory tract infection (URTI) event, and Survival situation. Follow up every 3 months for 1 year.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients with confusion, consciousness disorders, dementia, and various mental illnesses;
- •Patients with neuromuscular diseases and long-term bed rest who are at risk of aspiration;
- •Patients infected with HIV infection or other immunodeficiency diseases;
- •Participants in clinical trials of other drugs;
- •Known to be allergic to treatment drugs.
研究组 & 干预措施
TCM Group
The study will include adult patients discharged after hospitalization for pneumonia, with no restrictions on TCM syndromes. Patients diagnosed with pneumonia via laboratory or imaging tests at admission and treated in the hospital will be eligible if enrolled within seven days of discharge. Follow-ups will occur every three months over one year, documenting treatment methods (TCM or Western medicine), hospitalizations, respiratory infections, mortality, and quality of life.
Subgroup analyses will be conducted based on age, type of pneumonia (community- or hospital-acquired), specific TCM treatments (e.g., Chinese patent medicines or external therapies), and treatment duration.
干预措施: TCM (Drug)
结局指标
主要结局
Rehospitalization rate
时间窗: The Rehospitalization rate within a one-year follow-up period
Including all-cause readmission rate and pulmonary infection readmission rate
次要结局
- Health survey summary table（SF-36）(Changes in SF-36 relative to baseline at months 3, 6, 9, and 12 during the follow-up phase)
- nutritional status(Changes in nutritional status of CAP patients relative to baseline at 6 and 12 months of follow-up stage)
- Patient satisfaction with efficacy(Changes in ESQ-COPD relative to baseline at months 3, 6, 9, and 12 during the follow-up phase)
- Clinical outcomes reported by patients(Changes in CAP-PRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase)
- Clinical outcomes reported by doctors(Changes in CAP-CRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase)
- Acute upper respiratory tract infection (URTI) event(Acute upper respiratory tract infection events that occurred during the one-year follow-up period)
- Survival situation(Changes in patient survival situation relative to baseline at months 3, 6, 9, and 12 during the follow-up phase)