REspiratory diSEAse cohoRt Studies of CHinese Medicine for CAP (RESEARCH- CAP)

Not yet recruiting

• Conditions: Pneumonia
• Interventions: Drug: TCM

• Registration Number: NCT06220019
• Lead Sponsor: Henan University of Traditional Chinese Medicine

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-01-05
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-23
• Status Verified: 2024-09
• Study Start: 2024-12-26
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1078

Inclusion Criteria

Not provided

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TCM Group	TCM	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.

Primary Outcome Measures

Name	Time	Method
Rehospitalization rate	The Rehospitalization rate within a one-year follow-up period	Including all-cause readmission rate and pulmonary infection readmission rate

Secondary Outcome Measures

Name	Time	Method
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
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.
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.
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.
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.