AzTrials
AzTrials

MultimorbidityPOPMIX-SmokingNCT06458205

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

A study testing Multi-component intervention for smokers in people with Multimorbidity and Tobacco Use Cessation, run by Peking Union Medical College at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 35 years and older
What is being tested?
Multi-component intervention for smokers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,247 participants
Where
1 siteChina
Study dates
17 Jun 2024to 31 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Xishui County for Xishui Trial

    Zunyi, Guizhou

Other trials in China

About this study

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

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.

Read more

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.

Being tested
Multi-component intervention for smokers
Medical subject headings
Tobacco Use Cessation, Smoking Reduction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-component intervention for smokersCombination product

    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.
Study groups in NCT06458205
Study groupRoleWhat they receive
Intervention armExperimentalFor 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.
Receives: Combination Product: Multi-component intervention for smokers
Control ArmNo interventionWe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of smoking

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

    Measured: 1 year

  2. 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

    Measured: 1 year

Secondary outcomes (34)
  1. 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.

    Measured: 1 year

  2. 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;

    Measured: 1 year

  3. 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.

    Measured: 1 year

  4. FEV1 measurement

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

    Measured: 1 year

  5. COPD Screening

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

    Measured: 1 year

  6. Self-awareness of COPD

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

    Measured: 1 year

  7. COPD-Knowledge

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

    Measured: 1 year

  8. 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;

    Measured: 1 year

  9. 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;

    Measured: 1 year

  10. Blood pressure

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

    Measured: 1 year

  11. Blood Glucose

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

    Measured: 1 year

  12. Waist circumference

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

    Measured: 1 year

  13. BMI

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

    Measured: 1 year

  14. Number of Outpatient Visits

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

    Measured: 1 year

  15. Number of Inpatient Visits

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

    Measured: 1 year

  16. Medical expenditure within a family over the past year

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

    Measured: 1 year

  17. 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.

    Measured: 1 year

  18. 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.

    Measured: 1 year

  19. 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.

    Measured: 1 year

  20. 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

    Measured: 1 year

  21. 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;

    Measured: 1 year

  22. HBP Diagnosis

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

    Measured: 1 year

  23. 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;

    Measured: 1 year

  24. HBP Control

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

    Measured: 1 year

  25. 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;

    Measured: 1 year

  26. T2DM Diagnosis

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

    Measured: 1 year

  27. 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;

    Measured: 1 year

  28. T2DM Control

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

    Measured: 1 year

  29. Smoking Status

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

    Measured: 1 year

  30. Drinking Status

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

    Measured: 1 year

  31. Sugar Consumption

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

    Measured: 1 year

  32. Salted Vegetables Consumption

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

    Measured: 1 year

  33. Vegetable Consumption

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

    Measured: 1 year

  34. Physical exercise

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study start17 Jun 2024
  3. Primary completion31 Mar 2026
  4. Study completion31 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06458205
Sponsor's protocol ID
CAMS&PUMC-IEC-2024-042
Acronym
POPMIX-Smoking
Status last verified
Apr 2026
First submitted
9 Jun 2024
Last updated
4 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chen S, Huang K, Zheng Z, Liu Y, Zhang S, Chen W, Tang X, Cao Z, Tang L, Tong X, Zhao J, He L, Jiao L, Wang Y, Zhao T, Luo Y, Lai Q, Lyu X, Dou R, Chen Q, Bunker A, Vollmer S, Geldsetzer P, Jamison D, Barnighausen T, Yang T, Wang C; POPMIX study investigators. Impact of the POPulation Medicine Multimorbidity Intervention in Xishui County (POPMIX) on people at high risk for COPD who smoke: protocol for the POPMIX-Smoking cluster randomised controlled trial. BMJ Open. 2026 May 6;16(5):e112179. doi: 10.1136/bmjopen-2025-112179.

    PubMed 42091148

Questions about this trial

What is this clinical trial studying?

A study testing Multi-component intervention for smokers in people with Multimorbidity and Tobacco Use Cessation, run by Peking Union Medical College at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of smoking (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06458205, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in