Primary Health Management for Chronic Obstructive Pulmonary Disease

NCT ID: NCT06573580

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-04
• Study Completion Date: 2025-08-31

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.

Conditions

Pulmonary Disease; Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Usual primary health care for COPD

Group Type: NO_INTERVENTION

No interventions assigned to this group

The essential public health primary care for COPD

Group Type: EXPERIMENTAL

The essential public health service（EPHS）for COPD

Intervention Type: OTHER

Each group plans to recruit 3,000 participants. For the intervention group, the community-based management includes adding COPD management-related content to the primary public health service. This includes: Providing at least four follow-ups during the project at the 3rd, 6th, 9th, and 12th months. During each follow-up, patients must complete the "COPD Patient Follow-up Questionnaire" and receive oral health education and targeted clinical advice from the general practitioner (GP). In addition, the GPs must also distribute educational booklets and materials, record symptom assessment results and acute exacerbation situations, and provide targeted clinical advice and clinical decisions to the COPD patients according to the checklist of Chinese guideline for management of COPD in primary care. At the baseline and the last follow-up, patients need to undergo a routine physical examination, pulmonary function test, and bronchodilator test at their community health centers

Interventions

The essential public health service（EPHS）for COPD

Each group plans to recruit 3,000 participants. For the intervention group, the community-based management includes adding COPD management-related content to the primary public health service. This includes: Providing at least four follow-ups during the project at the 3rd, 6th, 9th, and 12th months. During each follow-up, patients must complete the "COPD Patient Follow-up Questionnaire" and receive oral health education and targeted clinical advice from the general practitioner (GP). In addition, the GPs must also distribute educational booklets and materials, record symptom assessment results and acute exacerbation situations, and provide targeted clinical advice and clinical decisions to the COPD patients according to the checklist of Chinese guideline for management of COPD in primary care. At the baseline and the last follow-up, patients need to undergo a routine physical examination, pulmonary function test, and bronchodilator test at their community health centers

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ting YANG

Deputy Director of the National Center for Respiratory Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ting Yang

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Chen Wang

Role: STUDY_CHAIR

Chinese Academy of Medical Sciences and Peking Union Medical College

Locations

China-japan Friendship Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2024-HX-59

Identifier Type: -

Identifier Source: org_study_id