REspiratory diSEAse cohoRt Studies of CHinese Medicine for Pneumonia (RESEARCH-Pneumonia)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TCM.
- Who it may be relevant to
- Registry conditions: Pneumonia. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug TCM
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.
Primary outcome measures
- Rehospitalization rate [Time frame: The Rehospitalization rate within a one-year follow-up period]
Secondary outcome measures (7)
- Patient satisfaction with efficacy [Time frame: Changes in ESQ-COPD relative to baseline at months 3, 6, 9, and 12 during the follow-up phase]
- Health survey summary table（SF-36） [Time frame: Changes in SF-36 relative to baseline at months 3, 6, 9, and 12 during the follow-up phase]
- Clinical outcomes reported by patients [Time frame: Changes in CAP-PRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase]
- Clinical outcomes reported by doctors [Time frame: Changes in CAP-CRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase]
- nutritional status [Time frame: Changes in nutritional status of CAP patients relative to baseline at 6 and 12 months of follow-up stage]
- Acute upper respiratory tract infection (URTI) event [Time frame: Acute upper respiratory tract infection events that occurred during the one-year follow-up period]
- Survival situation [Time frame: Changes in patient survival situation relative to baseline at months 3, 6, 9, and 12 during the follow-up phase]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06220019 · RESEARCH-Pneumonia