An interventional study of Multi-component intervention package in Multimorbidity, Population Medicine and Chronic Obstructive Pulmonary Disease, sponsored by Peking Union Medical College. Completed at 1 site in China. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Peking Union Medical College · Not applicable, Interventional, and Health services research
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.
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Exclusion Criteria:
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.
Combination Product: Multi-component intervention package
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.
1. Community-based spirometry pulmonary function tests and result interpretations and health education for COPD; 2. A digital health intervention program, NicQuit, for smokers(very familiar with intelligent mobile phone); 3. A digital health intervention program, EmoEase, for individuals whose WEMWBS questionnaire score is lower than 45(very familiar with intelligent mobile phone); 4. Health education to smokers for smoking cessation; 5. Health education to individuals with mental health issues; 6. Encouragement to seek professional medication treatment in superior hospitals for spirometry-defined COPD patients; 7. To actively include individuals whose blood pressurei s higher than 140/90 mmHg or/and whose random blood glucose higher than 11.1 mmol/L into the National Essential Public Health Service in China; 8. A CBT-based health education to the BMI abnormal, i.e., BMI \> 24.0 or BMI \< 18.5; 9. Pay-for-population mechanism for medical practitioners.
Number of Chronic Diseases Controlled
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.
Time frame: 1 year
Lung function testing
Definition: Have you ever had a pulmonary function test?; Variable type: Binary; Measurement: Respondent's answer to the question;
Time frame: 1 year
FEV1 measurement
Definition: Forced Expiratory Volume in one second (FEV1); Variable type: Continuous; Measurement: Pulmonary function test, portable spirometry;
Time frame: 1 year
Self-rated health status
Definition: General self-assessed health status; Variable type: Continuous; Measurement: EQ-5D-5L scale; Introduction to EQ-5D-5L scale: The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group in 2009 to improve the instrument's sensitivity and to reduce ceiling effects, as compared to the EQ-5D-3L. The scale could be transferred to health utility value, ranging from 0 to 1 continuously. 0 represents death and 1 represents perfect health
Time frame: 1 year
COPD knowledge
Definition: Excerpt from COPD-KQ, selecting questions that test the COPD knowledge for population; Variable type: Continuous; Measurement: COPD-KQ excerpt; Introduction to COPD-KQ excerpt: An excerpt from COPD knowledge questionnaire, which contains 9 questions which we consider could be beneficial to general population to enhance the common knowledge of COPD. Minimum value is 0 and maximum value is 9, the higher the value, the more correct statements one has chosen.
Time frame: 1 year
Self-awareness of COPD
Definition: Have you ever been diagnosed with COPD?; Variable type: Binary; Measurement: Respondent's answer to the question;
Time frame: 1 year
COPD treatment adherence
Definition: Are you currently receiving a COPD treatment plan prescribed by a doctor or other healthcare professional?; Variable type: Binary; Measurement: Respondent's answer to the question;
Time frame: 1 year
COPD control
Definition: Has the number of acute exacerbations decreased in the past six months?; Variable type: Binary; Measurement: Respondent's answer to the question;
Time frame: 1 year
CAT score
Definition: CAT questionnaire for COPD patients; Variable type: Continuous; Measurement: Respondent's answer to the question; Introduction to CAT questionnaire: COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The scope ranges from 0 to 40, the higher the score, the worse the COPD conditions.
Time frame: 1 year
mMRC score
Definition: mMRC questionnaire ; Variable type: Categorical; Measurement: Respondent's answer to the question; Introduction to mMRC: Modified Medical Research Council, categorical value, level 0 represents a good respiratory condition, while the maximum level 4 represents a very bad respiratory condition.
Time frame: 1 year
Number of outpatient visits
Definition: Outpatient visits and type of hospital; Variable type: Count; Measurement: Insurance/outpatient data/survey data
Time frame: 1 year
Number of inpatient visits
Definition: Inpatient visits and type of hospital; Variable type: Count; Measurement: Insurance/inpatient data/survey data
Time frame: 1 year
Medical expenditure within a family over the past year
Definition: Healthcare-related expenditures; Variable type: Continuous; Measurement: Survey data/insurance/outpatient/inpatient data;
Time frame: 1 year
Depression Symptoms
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.
Time frame: 1 year
Anxiety Symptoms
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.
Time frame: 1 year
Warwick-Edinburgh Mental Well-being Scale, WEM -WBS score
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.
Time frame: 1 year
Blood pressure
Definition: Systolic and diastolic blood pressure (mmHg); Variable type: Continuous; Measurement: Omron portable automatic blood pressure monitor;
Time frame: 1 year
Blood Glucose
Definition: Reference standard for average plasma glucose concentration over a period of time; Variable type: Continuous; Measurement: Blood glucose meter;
Time frame: 1 year
Waist circumference
Definition: Waist circumference (cm); Variable type: Continuous; Measurement: Soft measuring tape;
Time frame: 1 year
BMI
Definition: Body mass index (BMI), weight divided by height squared (kg/m²); Variable type: Continuous; Measurement: Calculation;
Time frame: 1 year
Family level annual consumption expenditure
Definition: Annual total household expenditure (self-reported); Variable type: Categorical; Measurement: Answer to a series of questions covering local expenditure categories by the household representative;
Time frame: 1 year
Employment status
Definition: Main occupation and type; Variable type: Categorical; Measurement: Respondent's answer to the question;
Time frame: 1 year
HBP Screening
Definition: Have you ever had your blood pressure measured by a doctor, nurse, or other healthcare professional?; Variable type: Binary; Measurement: Respondent's answer to the question;
Time frame: 1 year
HBP Diagnosis
Definition: Have you ever been diagnosed with hypertension by a doctor?; Variable type: Binary; Measurement: Respondent's answer to the question;
Time frame: 1 year
HBP Treatment
Definition: Are you currently taking any antihypertensive medication prescribed by a doctor or other healthcare professional? Variable type: Binary; Measurement: Respondent's answer to the question;
Time frame: 1 year
HBP Control
Definition: Blood pressure within the normal range at the end-of-year follow-up; Variable type: Binary; Measurement: Blood pressure measurement;
Time frame: 1 year
T2DM Screening
Definition: Have you ever had your blood glucose measured by a doctor, nurse, or other healthcare professional? Variable type: Binary; Measurement: Respondent's answer to the question;
Time frame: 1 year
T2DM Diagnosis
Definition: Have you ever been diagnosed with T2DM by a doctor?; Variable type: Binary; Measurement: Respondent's answer to the question;
Time frame: 1 year
T2DM Treatment
Definition: Are you currently receiving a type 2 diabetes treatment plan prescribed by a doctor or other healthcare professional?; Variable type: Binary; Measurement: Respondent's answer to the question;
Time frame: 1 year
T2DM Control
Definition: Blood glucose within the normal range at the end-of-year follow-up; Variable type: Binary; Measurement: Blood glucose measurement;
Time frame: 1 year
Smoking status
Definition: Do you currently smoke? Variable type: Binary/Categorical; Measurement: Respondent's answer to the question;
Time frame: 1 year
Smoking Amount
Definition: How many cigarettes do you smoke per day on average?; Variable type: Count; Measurement: Respondent's answer to the question;
Time frame: 1 year
Drinking Status
Definition: Frequency of alcohol consumption in the past 3 months; Variable type: Categorical; Measurement: Respondent's answer to the question;
Time frame: 1 year
Sugar Consumption
Definition: Frequency of consumption of sugary foods/drinks; Variable type: Categorical; Measurement: Respondent's answer to the question;
Time frame: 1 year
Salted Vegetables Consumption
Definition: Frequency of consumption of salty vegetables; Variable type: Categorical; Measurement: Respondent's answer to the question;
Time frame: 1 year
Vegetable Consumption
Definition: Frequency of consumption of vegetable; Variable type: Categorical; Measurement: Respondent's answer to the question;
Time frame: 1 year
Physical exercise
Definition: Frequency of physical exercise; Variable type: Categorical; Measurement: Respondent's answer to the question;
Time frame: 1 year
Asthma knowledge
Excerpt of PAKQ, selecting questions that general population should know in terms of asthma, ranging from 0 to 7, the higher the score, the more correct statements the respondents has chosen.
Time frame: 1 year
Saint George Respiratory Questionnaire score
Definition: SGRQ questionnaire for COPD patients; Variable type: continuous Measurement: Respondent's answer to the questions; Introduction to SGRQ: Saint George Respiratory Questionnaire score, ranging from 0 to 100, where 0 represents the best possible health status and 100 represents the worst possible health status.
Time frame: 1 year
ACT score
Definition: Asthma control test score; Variable type: Continuous; Measurement: Respondent's answer to the questions; Introduction to ACT score: Asthma control test (ACT), ranging from 0 to 25, the lower the score, the better asthma controlled
Time frame: 1 year
Asthma diagnosis
Definition: Have you ever diagnosed as asthma patient by professional physician? Variable type: Binary; Measurement: Respondent's answer to the question;
Time frame: 1 year
Smoking dependence
Fagerström test for nicotine dependence (FTND) is a scale that measures the nicotine dependence of smokers, ranging from 0 to 10, the higher the value, the worse the nicotine dependence will be. Heaviness Index of Smoking (HIS) could also be calculated using part of the scale, ranging from 0 to 6, and higher score means worse nicotine dependence.
Time frame: 1 year
Productivity loss
Working Productivity and Activity Impairment-General Health (WAPI-GH) Chinese version 2.0 is used. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, as follows: Questions: 1. = currently employed 2. = hours missed due to health problems 3. = hours missed other reasons 4. = hours actually worked 5. = degree health affected productivity while working 6. = degree health affected regular activities Scores: Multiply scores by 100 to express in percentages. Percent work time missed due to health: Q2/(Q2+Q4) Percent impairment while working due to health: Q5/10 Percent overall work impairment due to health: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4)))x(Q5/10)\] Percent activity impairment due to health: Q6/10
Time frame: 1 year
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Peking Union Medical College