Population Medicine Multimorbidity Interventions in Xishui on a High-Risk COPD Population: A Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9,319
- 试验地点
- 1
- 主要终点
- Lung function testing
研究概览
简要总结
Study Participants: High-risk COPD population, defined as individuals whose score of COPD-SQ is 16 and above and whose age is 35 and above. COPD-SQ questionnaire will be assigned to a representative sample of local residents in Xishui County, and they will finish the questionnaire online through mobile phone.
Intervention: Within the intervention arm, we have constructed a population-based pay-for-performance mechanism to encourage medical practitioners to care for population health. For study participants in the intervention arm, we will ask them to finish an online COPD-SQ questionnaire with notification of his or her COPD high risk status. Those whose score exceeds 16 will be invited to do a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For High-risk COPD population in the intervention arm, we provide community-based spirometry pulmonary function test (PFT) and education; If individuals whose post-bronchodilator FEV1/FVC<0.7, they will be spirometry-defined COPD patients and will be encouraged to seek treatment and medication to the superior hospitals. Additionally, we provide (1) two digital health intervention programs to smokers and individuals with mental health issues; (2) CBT-based health education for study participants with abnormal BMI; (3) active recruitment into National Essential Public Health Program in China for those with abnormal blood pressure and blood glucose. Intensive follow-ups will be conducted at month 3 (telephone interview), month 6 (face-to-face with full steps of physical examination), and month 12.
Comparison: Those who are assigned in the control arm, we will ask them to finish the same COPD-SQ online questionnaire with notification of his or her COPD high risk status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given.
Outcomes: The primary outcomes are COPD knowledge, COPD screening, and FEV1 measurement at month 12.
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
- None
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
- •Aged 35 and above;
- •COPD-SQ score is 16 and above;
- •Residents who have lived in one township over the past 3 months and plan to reside in the same township in the upcoming year;
- •Finished the informed consent.
排除标准
- •Pregnancy and other conditions that are not allowed to finish pulmonary function tests;
- •Severe cognitive disorder or total loss of capability of daily living
研究组 & 干预措施
Control Arm
Those who are assigned in the control arm, we will ask them to finish the same COPD-SQ online questionnaire with notification of his or her COPD high risk status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given at baseline. However, at month 12, we will provide community-based pulmonary function tests and physical examinations besides face-to-face survey.
Intervention arm
Within the intervention arm, all medical practitioners will be under a pay-for-population mechanism to incentivize them to care for the overall population health within their township. For High-risk COPD population in the intervention arm, we provide community-based spirometry pulmonary function test (PFT) and education; If individuals whose post-bronchodilator FEV1/FVC<0.7, they will be spirometry-defined COPD patients and will be encouraged to seek treatment and medication to the superior hospitals. Additionally, we provide (1) two digital health intervention programs to smokers and individuals with mental health issues; (2) CBT-based health education for study participants with abnormal BMI; (3) active recruitment into National Essential Public Health Program in China for those with abnormal blood pressure and blood glucose. Intensive follow-ups will be conducted at month 3 (telephone interview), month 6 (face-to-face with full steps of physical examination), and month 12.
干预措施: Multi-component intervention package (Combination Product)
结局指标
主要结局
Lung function testing
时间窗: 1 year
Definition: Have you ever had a pulmonary function test?; Variable type: Binary; Measurement: Respondent's answer to the question;
FEV1 measurement
时间窗: 1 year
Definition: Forced Expiratory Volume in one second (FEV1); Variable type: Continuous; Measurement: Pulmonary function test, portable spirometry;
Number of Chronic Diseases Controlled
时间窗: 1 year
Among all objectively measured health conditions and diseases (COPD, asthma, BMI, hypertension, Type 2 diabetes, depression symptoms, anxiety symptoms), the number of chronic diseases controlled defined by objective measurement at month 12.
次要结局
- Employment status(1 year)
- HBP Screening(1 year)
- HBP Diagnosis(1 year)
- HBP Treatment(1 year)
- HBP Control(1 year)
- T2DM Screening(1 year)
- T2DM Diagnosis(1 year)
- T2DM Treatment(1 year)
- T2DM Control(1 year)
- Smoking status(1 year)
- Smoking Amount(1 year)
- Drinking Status(1 year)
- Sugar Consumption(1 year)
- Salted Vegetables Consumption(1 year)
- Vegetable Consumption(1 year)
- Asthma knowledge(1 year)
- Saint George Respiratory Questionnaire score(1 year)
- ACT score(1 year)
- Asthma diagnosis(1 year)
- Number of inpatient visits(1 year)
- Medical expenditure within a family over the past year(1 year)
- Self-rated health status(1 year)
- COPD knowledge(1 year)
- Self-awareness of COPD(1 year)
- COPD treatment adherence(1 year)
- COPD control(1 year)
- CAT score(1 year)
- mMRC score(1 year)
- Number of outpatient visits(1 year)
- Depression Symptoms(1 year)
- Anxiety Symptoms(1 year)
- Warwick-Edinburgh Mental Well-being Scale, WEM -WBS score(1 year)
- Blood pressure(1 year)
- Blood Glucose(1 year)
- Waist circumference(1 year)
- BMI(1 year)
- Family level annual consumption expenditure(1 year)
- Productivity loss(1 year)
- Physical exercise(1 year)
- Smoking dependence(1 year)
研究者
Simiao Chen
Professor
Peking Union Medical College