Pilot Project for the Primary Health Management of Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Self-rated Quality of Life
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 35 years.
- •Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the 2024 GOLD guidelines.
- •Post-bronchodilator FEV1(Forced Expiratory Volume in one second) predicted ≥ 30%.
排除标准
- •Inability to provide informed consent.
- •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.
- •Currently participating in, or planning to participate in, any other COPD health management or clinical intervention projects during the study period.
结局指标
主要结局
Self-rated Quality of Life
时间窗: 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
时间窗: 12 months
The number of exacerbations occurred
次要结局
- Change in lung function(6 months 12 months)
- Oxygen desaturation(12 months)
- Degree of dyspnea (daily activity)(12 months)
研究者
Ting YANG
Deputy Director of the National Center for Respiratory Medicine
China-Japan Friendship Hospital