Population Medicine Multimorbidity Interventions in Xishui on a High-Risk COPD Population With Mental Health Symptoms: 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
- 3,571
- 试验地点
- 1
- 主要终点
- Depression Symptoms
研究概览
简要总结
Study Participants: High-risk COPD population with mental health symptoms, defined as individuals whose score of COPD-SQ ≥ 16, whose age is 35 and above, and whose Warwick-Edinburgh Mental Well-being Scale <45 .
Intervention: We have constructed a pay-for-population mechanism for medical practitioners within the intervention townships to encourage them caring 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. For those with high-risk COPD population, we will provide face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For high-risk COPD population with mental health issues 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. A CBT-based digital health intervention program, EmoEase, will be provided to our study participants with an intelligent mobile phone. Also health education in terms of mental health issues will be given. Additionally, we provide (1) a digital health intervention programs to smokers; (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 PHQ-9 scores for depression symptoms, GAD-7 symptoms for anxiety symptoms, and WEM-WBS 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;
- •High-risk COPD population, defined by score of COPD-SQ ≥ 16;
- •Mental health issues, defined by WEM-WBS scale < 45;
- •Local residents who stay within a township in the previous 3 months and plan to stay within the same township for the next 12 months.
排除标准
- •Those who suffer from severe cognitive disorder or total loss of ability of daily living.
研究组 & 干预措施
Intervention arm
We have constructed a pay-for-population mechanism to encourage medical workers caring for population health. We will ask study populations to finish online COPD-SQ questionnaire with notification of his or her COPD high risk status. For high-risk COPD population, we will provide a face-to-face survey and examination, and provide a multi-component intervention at baseline. We give community-based spirometry pulmonary function test and education; If individuals who are COPD patients, they will be encouraged to seek treatment to the superior hospitals. A CBT-based digital health program will be provided. Also health education will be given. Additionally, we provide (1) a digital health intervention programs to smokers; (2) CBT-based health education for the abnormal BMI; (3) active recruitment into National Essential Public Health Program for those with high blood pressure and blood glucose. Intensive follow-ups will be conducted at month 3, 6, 12.
干预措施: Multi-component Interventions (Combination Product)
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.
结局指标
主要结局
Depression Symptoms
时间窗: 1 year
Definition: Emotional disorders, including sadness, loss, and anger; Variable type: Continuous; Measurement: PHQ-9; Introduction to PHQ-9: Patient Health Questionnaire- 9 items (PHQ-9), ranging from 0 to 27, the higher the score, the severer the depression symptoms for the respondents will be.
Warwick-Edinburgh Mental Well-being Scale, WEM -WBS
时间窗: 1 year
Definition: Reflects overall mental health problems; Variable type: Continuous; Measurement: WEMWBS; Introduction to WEMWBS: Warwick-Edinburgh Mental Well-being Scale, ranging from 14 to 70, the lower the score, the worse one's general mental health will be.
Anxiety Symptoms
时间窗: 1 year
Definition: Unpleasant state of inner turmoil; Variable type: Continuous; Measurement: GAD-7; Introduction to GAD-7: General Anxiety Disorder - 7 (GAD-7), ranging from 0 to 21, the higher the score, the severer the anxiety symptoms for the respondents will be.
次要结局
- Number of chronic diseases controlled(1 year)
- Self-awareness of COPD(1 year)
- COPD-Knowledge(1 year)
- Treatment adherence(1 year)
- COPD control(1 year)
- Blood pressure(1 year)
- Blood Glucose(1 year)
- Waist circumference(1 year)
- BMI(1 year)
- Outpatient(1 year)
- Inpatient(1 year)
- Medical expenditure within a family over the past year(1 year)
- Self-rated health status(1 year)
- FEV1 measurement(1 year)
- mMRC score(1 year)
- CAT score(1 year)
- COPD Screening(1 year)
- Productivity Loss(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)
- Physical exercise(1 year)
- Smoking Dependence(1 year)
研究者
Simiao Chen
Professor
Peking Union Medical College