Status:
ACTIVE_NOT_RECRUITING
Primary Health Management for Chronic Obstructive Pulmonary Disease
Lead Sponsor:
China-Japan Friendship Hospital
Conditions:
Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
35+ years
Phase:
NA
Brief Summary
The core objective of the "Pilot Project for the Primary Health Management of Chronic Obstructive Pulmonary Disease (COPD)" is to explore a primary health management model and service standards that a...
Eligibility Criteria
Inclusion
- Age ≥ 35 years.
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the 2024 GOLD guidelines.
- Post-bronchodilator FEV1(Forced Expiratory Volume in one second) predicted ≥ 30%.
Exclusion
- Inability to provide informed consent.
- Contraindications for pulmonary function tests, including:
- Recent myocardial infarction, stroke, or shock within the past 3 months.
- Severe heart failure, severe arrhythmias, or unstable angina within the past 4 weeks.
- Recent major hemoptysis within the past 4 weeks.
- Major thoracic, abdominal, or ophthalmic surgery within the past 3 months.
- Psychiatric disorders requiring antipsychotic medication or with a history of seizures requiring medication.
- Cognitive impairment, including dementia or severe comprehension deficits.
- Uncontrolled hypertension (systolic blood pressure \> 200 mmHg, diastolic blood pressure \> 100 mmHg).
- Resting heart rate \> 120 beats per minute.
- Presence of aortic aneurysm.
- Severe hyperthyroidism.
- Pregnancy or lactation.
- Respiratory tract infections (e.g., tuberculosis, influenza, pneumonia) within the past month.
- Presence of pneumothorax, large pulmonary bullae not scheduled for surgery, or tympanic membrane perforation.
- Currently participating in, or planning to participate in, any other COPD health management or clinical intervention projects during the study period.
Key Trial Info
Start Date :
July 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
6000 Patients enrolled
Trial Details
Trial ID
NCT06573580
Start Date
July 4 2024
End Date
August 31 2025
Last Update
August 27 2024
Active Locations (1)
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1
China-japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029