Primary Health Management for Chronic Obstructive Pulmonary Disease

Not Applicable

Active, not recruiting

• Conditions: Pulmonary Disease; Chronic Obstructive Pulmonary Disease
• Interventions: Other: The essential public health service（EPHS）for COPD

• Registration Number: NCT06573580
• Lead Sponsor: China-Japan Friendship Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-04
• Study First Submitted: 2024-07-26
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-25
• Last Update Submitted: 2024-08-25
• Study First Posted: 2024-08-27
• Last Update Posted: 2024-08-27
• Primary Completion: 2025-07-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The essential public health primary care for COPD	The essential public health service（EPHS）for COPD	-

Primary Outcome Measures

Name	Time	Method
Self-rated Quality of Life	12 months	Quality of life measured by the EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) questionnaire. It consists of two parts: Descriptive System: This includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, ranging from no problems to extreme problems.; Visual Analog Scale (VAS): This is a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state.; Scores from the descriptive system can be combined into a single health index value, while the VAS provides an immediate self-assessment of the respondent's health status. Higher scores indicate better health-related quality of life.
Acute exacerbation frequency	12 months	The number of exacerbations occurred

Secondary Outcome Measures

Name	Time	Method
Change in lung function	6 months 12 months	Decline in forced expiratory rate in one second (FEV1) before use of bronchodilator.
Oxygen desaturation	12 months	SpO2 measured by a pulse oximeter.
Degree of dyspnea (daily activity)	12 months	Measured by Modified Medical Research Council (mMRC) Dyspnea Questionnaire Minimum Value: 0 (no dyspnea) Maximum Value: 4 (severe dyspnea) It specifically assesses dyspnea based on the activity level at which shortness of breath occurs, ranging from 0 to 4. A score of 4 indicates that the patient experiences dyspnea with minimal activity, representing the most severe breathlessness.

Trial Locations

Locations (1)

China-japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China