Primary Health Management for Chronic Obstructive Pulmonary Disease
NCT Number: NCT06573580
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pulmonary Disease|Chronic Obstructive Pulmonary Disease
Interventions: OTHER: The essential public health service（EPHS）for COPD
Sponsor: China-Japan Friendship Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-04
Completion Date: 2025-08-31
Locations: China-japan Friendship Hospital, Beijing, Beijing, 100029, China

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.

Primary Outcome Measures: Acute exacerbation frequency, The number of exacerbations occurred, 12 months|Self-rated Quality of Life, 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., 12 months
Secondary Outcome Measures: Change in lung function, Decline in forced expiratory rate in one second (FEV1) before use of bronchodilator., 6 months 12 months|Degree of dyspnea (daily activity), 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., 12 months|Oxygen desaturation, SpO2 measured by a pulse oximeter., 12 months
Other Outcome Measures: Nicotine dependence, Measured by Fagerström Test for Nicotine Dependence (FTND); Minimum Value: 0 (no dependence); Maximum Value: 10 (high dependence); The FTND is a widely used clinical tool to assess the level of nicotine dependence. It consists of 6 questions, each with answers assigned different point values. The cumulative score determines the level of nicotine dependence. Higher cumulative scores indicate greater nicotine dependence., 12 months|Healthcare expenditure for COPD, An online survey questionnaire to collect indirect and direct non-medical costs for COPD treatment, along with data obtained from the Chinese National Healthcare Security Administration (NHSA) for the direct costs of treating and managing COPD., 12 months|Clinic or emergency utilization, Clinic or emergency utilization in the past six months and clinic types were collected by an online survey questionnaire and from the Chinese National Healthcare Security Administration (NHSA)., 6 months|Knowledge of Primary Health Care Providers, It is an online survey questionnaire designed by our team to explore the knowledge level of primary care physicians in China on COPD. The questionnaire includes components on COPD risk factors, screening, diagnosis, treatment and control, and public education., 12 months