Clinical trial NCT06573580: Primary Health Management for Chronic Obstructive Pulmonary Disease
Official title: Pilot Project for the Primary Health Management of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Keywords: Primary Health Management
Health Economic Evaluation
Efficacy
Community-based
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 6000
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Acute exacerbation frequency
timeFrame: 12 months
measure: Self-rated Quality of Life
timeFrame: 12 months
Secondary outcomes:
measure: Change in lung function
timeFrame: 6 months 12 months
measure: Degree of dyspnea (daily activity)
timeFrame: 12 months
measure: Oxygen desaturation
timeFrame: 12 months
Other outcomes:
measure: Nicotine dependence
timeFrame: 12 months
measure: Healthcare expenditure for COPD
timeFrame: 12 months
measure: Clinic or emergency utilization
timeFrame: 6 months
measure: Knowledge of Primary Health Care Providers
timeFrame: 12 months
Locations:
city: Beijing
country: China
facility: China-japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Ting Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese Academy of Medical Sciences and Peking Union Medical College
name: Chen Wang
role: STUDY_CHAIR
References: