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Completed

NCT Number: NCT06458205

Impact of Multi-Component Interventions on High-Risk COPD Smokers

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.

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Key information

Conditions

Multimorbidity Behavior Health Behavior Smoking Smoking Reduction Tobacco Use Cessation

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xishui County for Xishui Trial

Zunyi, Guizhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Those who suffer from severe cognitive disorder or total loss of ability of daily living.

Treatment and study plan

Multi-component intervention for smokers

Combination Product
  • Community-based spirometry pulmonary function tests and result interpretations and health education;
  • A digital health intervention program, NicQuit, for smokers(very familiar with intelligent mobile phone);
  • A digital health intervention program, EmoEase, for smokers whose WEMWBS questionnaire score is lower than 45(very familiar with intelligent mobile phone);
  • Health education to smokers for smoking cessation;
  • Health education to smokers with mental health issues;
  • Encouragement to seek professional medication treatment in superior hospitals for spirometry-defined COPD patients or asthma patients;
  • 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;
  • A CBT-based health education to the BMI abnormal, i.e., BMI > 24.0 or BMI <18.5;
  • Pay-for-population mechanism for medical practitioners.

Primary outcomes

  1. Amount of smoking

    Time frame: 1 year

    Definition: Average number of cigarettes smoked per day; Variable type: Continuous; Measurement: Respondent's answer to the question.

  2. Smoking Dependence

    Time frame: 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

Secondary outcomes

  1. Self-rate health status

    Time frame: 1 year

    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.

  2. Number of Chronic Conditions Controlled

    Time frame: 1 year

    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;

  3. Physical proof of cigarettes

    Time frame: 1 year

    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.

  4. FEV1 measurement

    Time frame: 1 year

    Definition: Forced Expiratory Volume in one second (FEV1); Variable type: Continuous; Measurement: Pulmonary function test, portable spirometry;

  5. COPD Screening

    Time frame: 1 year

    Definition: Have you ever had a pulmonary function test?; Variable type: Binary; Measurement: Respondent's answer to the question;

  6. Self-awareness of COPD

    Time frame: 1 year

    Definition: Have you ever been diagnosed with COPD?; Variable type: Binary; Measurement: Respondent's answer to the question;

  7. COPD-Knowledge

    Time frame: 1 year

    Definition: COPD Knowledge Questionnaire; Variable type: Continuous; Measurement: Respondent's answer to the questions;

  8. Treatment adherence

    Time frame: 1 year

    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;

  9. COPD control

    Time frame: 1 year

    Definition: Has the number of acute exacerbations decreased in the past six months?; Variable type: Binary; Measurement: Respondent's answer to the question;

  10. Blood pressure

    Time frame: 1 year

    Definition: Systolic and diastolic blood pressure (mmHg); Variable type: Continuous; Measurement: Omron portable automatic blood pressure monitor;

  11. Blood Glucose

    Time frame: 1 year

    Definition: Reference standard for average plasma glucose concentration over a period of time; Variable type: Continuous; Measurement: Blood glucose meter;

  12. Waist circumference

    Time frame: 1 year

    Definition: Waist circumference (cm); Variable type: Continuous; Measurement: Soft measuring tape;

  13. BMI

    Time frame: 1 year

    Definition: Body mass index (BMI), weight divided by height squared (kg/m²); Variable type: Continuous; Measurement: Calculation;

  14. Number of Outpatient Visits

    Time frame: 1 year

    Definition: Outpatient visits and type of hospital; Variable type: Count; Measurement: Survey/insurance/outpatient data;

  15. Number of Inpatient Visits

    Time frame: 1 year

    Definition: Inpatient visits and type of hospital; Variable type: Count; Measurement: Survey data/insurance/inpatient data;

  16. Medical expenditure within a family over the past year

    Time frame: 1 year

    Definition: Healthcare-related expenditures; Variable type: Continuous; Measurement: Survey/insurance/outpatient/inpatient data;

  17. Depression Symptoms

    Time frame: 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.

  18. Anxiety Symptoms

    Time frame: 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.

  19. Warwick-Edinburgh Mental Well-being Scale, WEM -WBS

    Time frame: 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.

  20. Productivity Loss

    Time frame: 1 year

    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:

    • = currently employed
    • = hours missed due to health problems
    • = hours missed other reasons
    • = hours actually worked
    • = degree health affected productivity while working
    • = 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

  21. HBP Screening

    Time frame: 1 year

    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;

  22. HBP Diagnosis

    Time frame: 1 year

    Definition: Have you ever been diagnosed with hypertension by a doctor?; Variable type: Binary; Measurement: Respondent's answer to the question;

  23. HBP Treatment

    Time frame: 1 year

    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;

  24. HBP Control

    Time frame: 1 year

    Definition: Blood pressure within the normal range at the end-of-year follow-up; Variable type: Binary; Measurement: Blood pressure measurement;

  25. T2DM Screening

    Time frame: 1 year

    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;

  26. T2DM Diagnosis

    Time frame: 1 year

    Definition: Have you ever been diagnosed with T2DM by a doctor?; Variable type: Binary; Measurement: Respondent's answer to the question;

  27. T2DM Treatment

    Time frame: 1 year

    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;

  28. T2DM Control

    Time frame: 1 year

    Definition: Blood glucose within the normal range at the end-of-year follow-up; Variable type: Binary; Measurement: Blood glucose measurement;

  29. Smoking Status

    Time frame: 1 year

    Definition: Do you currently smoke?; Variable type: Binary; Measurement: Respondent's answer to the question;

  30. Drinking Status

    Time frame: 1 year

    Definition: Frequency of alcohol consumption in the past 3 months; Variable type: Categorical; Measurement: Respondent's answer to the question;

  31. Sugar Consumption

    Time frame: 1 year

    Definition: Frequency of consumption of sugary foods/drinks; Variable type: Categorical; Measurement: Respondent's answer to the question;

  32. Salted Vegetables Consumption

    Time frame: 1 year

    Definition: Frequency of consumption of salty vegetables; Variable type: Categorical; Measurement: Respondent's answer to the question;

  33. Vegetable Consumption

    Time frame: 1 year

    Definition: Frequency of consumption of vegetable; Variable type: Categorical; Measurement: Respondent's answer to the question;

  34. Physical exercise

    Time frame: 1 year

    Definition: Frequency of physical exercise; Variable type: Categorical; Measurement: Respondent's answer to the question;

Sponsors and collaborators

Lead sponsor

Peking Union Medical College

Other

Collaborators

  • China-Japan Friendship Hospital

Registry information

Official study title

Population Medicine Multimorbidity Interventions in Xishui on High-risk COPD Smokers: A Cluster Randomized Controlled Trial

Acronym: POPMIX-Smoking

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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