Population Medicine Multimorbidity Interventions in Xishui on High-risk COPD Smokers: 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
- 4,247
- 试验地点
- 1
- 主要终点
- Amount of smoking
研究概览
简要总结
Study Participants: In our study, we focus on smokers who self-report a "current smoking" status or smoking cessation less than 6 months. This trial is a sub-trial of "Impact of Multi-Component Interventions on a High-Risk COPD population" (Protocol ID: CAMS&PUMC-IEC-2024-040). All smokers in this trial are either from the high-risk COPD population (defined by COPD-SQ score≥16) .
Intervention: 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. For those whose score of COPD-SQ ≥ 16, we will provide a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For smokers in the intervention arm, we provide a digital health intervention program, NicQuit, to whom could familiarly use intelligent mobile phones, and health education for all smokers. We also provide community-based spirometry pulmonary function test (PFT) and education to smokers. If smokers 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) another digital health intervention programs to smokers 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 self-reported average number of cigarettes consumed per day, smoking dependence index, and CO measurement.
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 the score of COPD-SQ ≥ 16;
- •Self-report currently smoking or smoking cessation less than 6 month;
- •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
Control Arm
We will notify smokers with high-risk COPD to seek further diagnoses in superior hospitals. We provide a face-to-face survey to smokers with high-risk COPD. No other specified interventions will be given, they will be always accessible to usual care within the study period.
Intervention arm
For all townships within the intervention arm, we have constructed a pay-for-population mechanism to incentivize all medical practitioners to care for population health within each township. For smokers, we will provide a multi-component intervention: (1) NicQuit, a CBT-based digital health intervention for those who use intelligent mobile phones; (2) community-based pulmonary function test; (3) health education and encouragement to seek medication in superior hospitals for those spirometry-defined COPD patients; (4) CBT-based health education to the abnormal BMI; (5) health education to smoking cessation; (6) Active recruitment of smokers with high blood pressure or high blood glucose measurement. Intensive follow-ups will be at month 3, 6, and 12.
干预措施: Multi-component intervention for smokers (Combination Product)
结局指标
主要结局
Amount of smoking
时间窗: 1 year
Definition: Average number of cigarettes smoked per day; Variable type: Continuous; Measurement: Respondent's answer to the question.
Smoking Dependence
时间窗: 1 year
Definition: A scale that measures the degree of smoking dependence; Variable type: Continuous; Measurement: Respondent's answer to the question. Introduction to Smoking Dependence Scale: Chinese version of Fagerström test for nicotine dependence (FTND), ranging from 0 to 10, the higher the score, the severer nicotine dependence will be. Also Heaviness of Smoking Index (HSI) will also be measured, ranging from 0 to 6, the higher the score, the worsen the nicotine dependence will be
次要结局
- Treatment adherence(1 year)
- COPD 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)
- 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(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)
- Drinking Status(1 year)
- Vegetable Consumption(1 year)
- Sugar Consumption(1 year)
- Salted Vegetables Consumption(1 year)
- Self-rate health status(1 year)
- Number of Chronic Conditions Controlled(1 year)
- Physical proof of cigarettes(1 year)
- FEV1 measurement(1 year)
- COPD Screening(1 year)
- Self-awareness of COPD(1 year)
- COPD-Knowledge(1 year)
- Productivity Loss(1 year)
- Physical exercise(1 year)
研究者
Simiao Chen
Professor
Peking Union Medical College