Population Medicine Multimorbidity Intervention in Xishui on a Suspected Asthma 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
- 9,194
- 试验地点
- 1
- 主要终点
- Lung function testing
研究概览
简要总结
Study Participants: Suspected asthma population, defined as individuals whose score of asthma screening questionnaire used in ECRHS study exceeds 0 and whose age is 35 and above.
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 ECRHS questionnaire with notification of his or her suspected asthma status. Individuals whose score of ECRHS asthma screening exceeds 0 will be given a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For suspected asthma population in the intervention arm, we provide community-based spirometry pulmonary function test (PFT) and education; If individuals whose FEV1 improved by ≥12% and ≥200 mL following bronchodilator administration with 400 ug salbutamol, they will be spirometry-defined undiagnosed asthma patient 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 ECRHS online questionnaire with notification of his or her suspected asthma status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given.
Outcomes: The primary outcomes are asthma knowledge, lung function testing, and ACT score 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;
- •Score of ECRHS asthma screening questionnaire exceeds 0;
- •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 ECRHS asthma screening online questionnaire with notification of his or her suspected asthma status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given.
Intervention arm
Within the intervention arm, all medical practitioners will be incentivized by a pay-for-population mechanism within their township. First, finish a ECRHS questionnaire with notification of suspected asthma risk status. Those noticed will be given a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For suspected asthma population, we provide community-based spirometry PFT and education; If individuals whose FEV1 improved by ≥12% and ≥200 mL, they will be undiagnosed asthma patients and encouraged to seek treatment to the superior hospitals. 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 for those with abnormal blood pressure and glucose. Intensive follow-ups will be conducted at month 3, 6, 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;
ACT score
时间窗: 1 year
Definition: Asthma Control Test score Variable type: Continuous; Measurement: Respondent's answer to the question; Introduction to ACT score: Asthma control test (ACT), ranging from 0 to 25, the lower the score, the better asthma controlled.
Number of Chronic Diseases Controlled
时间窗: 1 year
Among all objectively measured diseases (asthma, COPD, BMI, hypertensions, type 2 diabetes, depression symptoms, anxiety symptoms), the number of chronic diseases controlled defined by objective measurement at month 12.
次要结局
- Medical expenditure within a family over the past year(1 year)
- Depression Symptoms(1 year)
- Anxiety Symptoms(1 year)
- Warwick-Edinburgh Mental Well-being Scale, WEM -WBS score(1 year)
- Family level annual consumption expenditure(1 year)
- Employment status(1 year)
- Self-rated health status(1 year)
- Asthma Knowledge(1 year)
- Bronchial Asthma Screening(1 year)
- Bronchial Asthma Diagnosis(1 year)
- Bronchial Asthma Treatment(1 year)
- Bronchial Asthma Control(1 year)
- Blood pressure(1 year)
- Blood Glucose(1 year)
- Waist circumference(1 year)
- BMI(1 year)
- Number of Outpatient Visits(1 year)
- Number of Inpatient Visits(1 year)
- Productivity Loss(1 year)
- FEV1 measurement(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)
- Self-awareness of COPD(1 year)
- COPD-Knowledge(1 year)
- mMRC score(1 year)
- Physical exercise(1 year)
- Smoking Dependence(1 year)
研究者
Simiao Chen
Professor
Peking Union Medical College