Pneumonia
Conditions
Keywords
Pneumonia, Chinese Medicine, Cohort
Brief summary
The purpose of this study is to evaluate the clinical efficacy and safety of dialectical treatment in the patients with pneumonia 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.
Detailed description
The incidence, hospitalization rate, and mortality associated with pneumonia are significant, contributing to a substantial disease burden. Post-discharge follow-up and intervention strategies for pneumonia patients are often insufficient, leaving patients vulnerable to readmission or mortality due to recurrent pneumonia and related complications. In clinical practice, there is a predominant focus on the amelioration of clinical symptoms during hospitalization, with limited attention to ongoing outpatient interventions aimed at reducing readmission rates. Consequently, there is a pressing need for cohort studies on pneumonia. This study is a multicenter, prospective cohort study involving adult patients discharged after pneumonia treatment. Approximately 5,000 patients will be enrolled, with follow-up assessments conducted every three months over the course of one year. After one year, patients will be stratified into two cohorts based on the duration of Traditional Chinese medicine (TCM) treatment received (e.g., continuous treatment for two months or intermittent treatment for three months per year). One cohort will consist of patients receiving TCM, while the other will include those who did not receive TCM. The primary endpoint is the rate of hospital readmission, while secondary outcomes include treatment satisfaction, physician-reported outcomes, patient-reported outcomes, quality of life, nutritional status, incidence of acute upper respiratory tract infections, and survival. This study aims to evaluate the clinical efficacy and safety of TCM in the management of adult pneumonia patients following discharge.
Interventions
DRUGTCM
We will perform subgroup analyses based on specific TCM interventions (such as Chinese patent medicines or external therapies) and the duration of TCM treatment (for example, comparing patients who receive continuous oral Chinese patent medicine for two months or more each year with those who do not). These analyses will assess the efficacy and safety of TCM.
Sponsors
Wuhan No.1 Hospital
Hebei Provincial Hospital of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine
Qingdao Hiser Medical Group
The First Affiliated Hospital of Zhejiang Chinese Medical University
Shaanxi Hospital of Traditional Chinese Medicine
Henan University of Traditional Chinese Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Selection Criteria: * Hospitalized patients with a confirmed diagnosis of pneumonia (HAP, CAP). * Age ≥18 years. * Signed informed consent form.
Exclusion criteria
* Patients with confusion, consciousness disorders, dementia, and various mental illnesses; * Patients with altered mental status, dementia, consciousness disorders, or various psychiatric conditions; * Those who are completely unable to care for themselves or are bedridden long-term; and those currently participating in other clinical drug trials. * Known to be allergic to treatment drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rehospitalization rate | The Rehospitalization rate within a one-year follow-up period | Including all-cause readmission rate and pulmonary infection readmission rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Using SF-36 to evaluate the impact of CAP on a person's life over time |
| Clinical outcomes reported by patients | Changes in CAP-PRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase | The Patient Reported Outcome for CAP (CAP-PRO) was used to assess the quality of life and health status of patients with pneumonia. |
| Clinical outcomes reported by doctors | Changes in CAP-CRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase | The Clinical Reported Outcome for CAP (CAP CRO) was used to assess the patient's condition. |
| Patient satisfaction with efficacy | Changes in ESQ-COPD relative to baseline at months 3, 6, 9, and 12 during the follow-up phase | The Effectiveness Satisfaction Questionnaire of CAP (ESQ-CAP) was used to evaluate the efficacy of pneumonia patients. |
| Acute upper respiratory tract infection (URTI) event | Acute upper respiratory tract infection events that occurred during the one-year follow-up period | It is a general term for acute inflammation of the nose, pharynx, or throat caused by various viruses and/or bacteria, including common cold, acute viral pharyngitis or laryngitis, acute herpetic pharyngitis, pharyngoconjunctival fever, bacterial pharyngitis, and tonsillitis. |
| Survival situation | Changes in patient survival situation relative to baseline at months 3, 6, 9, and 12 during the follow-up phase | Record the number of deaths. Record the follow-up period every 3 months. |
| nutritional status | Changes in nutritional status of CAP patients relative to baseline at 6 and 12 months of follow-up stage | Nutritional status related indicators. |
Contacts
Primary ContactMinghang Wang, Doctor
Outcome results
None listed