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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
7,400
1. Community-based spirometry pulmonary function tests and result interpretations and health education; 2. A digital health intervention program, NicQuit, for smokers(very familiar with intelligent mobile phone); 3. A digital health intervention program, EmoEase, for smokers 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 smokers with mental health issues; 6. Encouragement to seek professional medication treatment in superior hospitals for spirometry-defined COPD patients or asthma patients; 7. To actively include smokers whose blood pressure's higher than 140/90 mmHg or/and whose random blood glucose higher than11.1mmol/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.
Xishui County for Xishui Trial
Zunyi, Guizhou, China
Amount of smoking
Definition: Average number of cigarettes smoked per day; Variable type: Continuous; Measurement: Respondent's answer to the question.
Time frame: 1 year
Smoking Dependence
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
Time frame: 1 year
Self-rate health status
Definition: General self-assessed health status; Variable type: Continuous; Measurement: EQ-5D 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
Number of Chronic Conditions Controlled
Definition: Among 7 objectively measured health conditions (COPD, asthma, depression symptoms, anxiety symptoms, BMI, hypertension, type 2 diabetes), the number of chronic conditions controlled; Variable type: Counting data; Measurement: Through objective physical examination or validated scale;
Time frame: 1 year
Physical proof of cigarettes
Definition: Can you show me your cigarettes? Variable type: Binary; Measurement: Self-report questions and to let respondents show to our field workers whether he or she brings cigarettes.
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
COPD Screening
Definition: Have you ever had a pulmonary function test?; Variable type: Binary; Measurement: Respondent's answer to the question;
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-Knowledge
Definition: COPD Knowledge Questionnaire; Variable type: Continuous; Measurement: Respondent's answer to the questions;
Time frame: 1 year
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
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
Number of Outpatient Visits
Definition: Outpatient visits and type of hospital; Variable type: Count; Measurement: Survey/insurance/outpatient data;
Time frame: 1 year
Number of Inpatient Visits
Definition: Inpatient visits and type of hospital; Variable type: Count; Measurement: Survey data/insurance/inpatient data;
Time frame: 1 year
Medical expenditure within a family over the past year
Definition: Healthcare-related expenditures; Variable type: Continuous; Measurement: Survey/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
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
Productivity Loss
Definition: Productivity loss due to illness or health problems; Variable type: Continuous; Measurement: Respondent's answer to the question; Introduction to WPAI-GH : Work Productivity and Activity Impairment-General Health (v2.0) Chinese version.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
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; 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
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