Clinical trial NCT06220019: REspiratory diSEAse cohoRt Studies of CHinese Medicine for Pneumonia (RESEARCH-Pneumonia)
Official title: REspiratory diSEAse cohoRt Studies of CHinese Medicine for Pneumonia (RESEARCH-Pneumonia)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pneumonia
Keywords: Pneumonia
Chinese Medicine
Cohort
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Wuhan No.1 Hospital
name: Hebei Provincial Hospital of Traditional Chinese Medicine
name: Shanghai University of Traditional Chinese Medicine
name: Qingdao Hiser Medical Group
name: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: Shaanxi Hospital of Traditional Chinese Medicine
First posted: 2024-01-23
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients discharged after pneumonia.

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.

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.

Primary outcomes:
measure: Rehospitalization rate
timeFrame: The Rehospitalization rate within a one-year follow-up period
Secondary outcomes:
measure: Patient satisfaction with efficacy
timeFrame: Changes in ESQ-COPD relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
measure: Health survey summary table（SF-36）
timeFrame: Changes in SF-36 relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
measure: Clinical outcomes reported by patients
timeFrame: Changes in CAP-PRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
measure: Clinical outcomes reported by doctors
timeFrame: Changes in CAP-CRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
measure: nutritional status
timeFrame: Changes in nutritional status of CAP patients relative to baseline at 6 and 12 months of follow-up stage
measure: Acute upper respiratory tract infection (URTI) event
timeFrame: Acute upper respiratory tract infection events that occurred during the one-year follow-up period
measure: Survival situation
timeFrame: Changes in patient survival situation relative to baseline at months 3, 6, 9, and 12 during the follow-up phase
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Jiansheng Li, Doctor
role: STUDY_CHAIR
References: