Primary Health Management for Chronic Obstructive Pulmonary Disease

China-Japan Friendship Hospital

Status: Active, not recruiting

Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Disease

Treatments: Other: The essential public health service（EPHS）for COPD

Study type: Interventional

Funder types: Other

Identifiers

NCT06573580

2024-HX-59

Details and patient eligibility

About

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 are suitable for COPD patients and aligned with grassroots realities. It also aims to enhance the capability of primary healthcare institutions in the prevention and management of chronic respiratory diseases. The primary outcomes are to evaluate the efficacy and cost-effectiveness of COPD Essential Public Health Services (EPHS) intervention in communities in China.

Participants are already receiving intervention B, "Usual primary health care," as part of their regular medical care under the current health policy. Researchers will compare intervention A, which is"the EPHS for COPD", with intervention B to determine if intervention A performs better in COPD management.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 35 years.
2. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the 2024 GOLD guidelines.
3. Post-bronchodilator FEV1(Forced Expiratory Volume in one second) predicted ≥ 30%.

Exclusion criteria

1. Inability to provide informed consent.

2. 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.

3. Currently participating in, or planning to participate in, any other COPD health management or clinical intervention projects during the study period.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6,000 participants in 2 patient groups

Usual primary health care for COPD

No Intervention group

The essential public health primary care for COPD

Experimental group

Treatment:

Other: The essential public health service（EPHS）for COPD