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MultimorbidityPOPMIX-AsthmaNCT06457009

Impact of Multi-Component Intervention on Suspected Asthma Population

A study testing Multi-component Intervention Package in people with Multimorbidity and Chronic Asthma, 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
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Trial summary

Study Participants: Suspected asthma population, defined as individuals whose score of asthma screening questionnaire used in ECRHS study exceeds 0 and whose age is 35 and above. Read more about this study

Who is it for?
Ages 35 years and older
What is being tested?
Multi-component Intervention Package
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,194 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;
  • Score of ECRHS asthma screening questionnaire exceeds 0;
  • Residents who have lived in one township over the past 3 months and plan to reside in the same township in the upcoming year;
  • Finished the informed consent

Who cannot join

  • Pregnancy and other conditions that are not allowed to finish pulmonary function tests;
  • Severe cognitive disorder or total loss of capability 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 Intervention in Xishui on a Suspected Asthma Population: A Cluster Randomized Controlled Trial

Study Participants: Suspected asthma population, defined as individuals whose score of asthma screening questionnaire used in ECRHS study exceeds 0 and whose age is 35 and above.

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 ECRHS questionnaire with notification of his or her suspected asthma status. Individuals whose score of ECRHS asthma screening exceeds 0 will be given a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For suspected asthma population in the intervention arm, we provide community-based spirometry pulmonary function test (PFT) and education; If individuals whose FEV1 improved by ≥12% and ≥200 mL following bronchodilator administration with 400 ug salbutamol, they will be spirometry-defined undiagnosed asthma patient 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.

Read more

Comparison: Those who are assigned in the control arm, we will ask them to finish the same ECRHS online questionnaire with notification of his or her suspected asthma status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given.

Outcomes: The primary outcomes are asthma knowledge, lung function testing, and ACT score at month 12.

Being tested
Multi-component Intervention Package
Keywords
Suspected Asthma, Multimorbidity Interventions and Management, Clustered RCT, Pay-for-population Mechanism

What participants receive

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

  • Multi-component Intervention PackageCombination product

    1. Community-based spirometry pulmonary function tests and result interpretations and health education for asthma;
    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 undiagnosed asthma patients;
    7. To actively include individuals whose blood pressure'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.
Study groups in NCT06457009
Study groupRoleWhat they receive
Intervention armExperimentalWithin the intervention arm, all medical practitioners will be incentivized by a pay-for-population mechanism within their township. First, finish a ECRHS questionnaire with notification of suspected asthma risk status. Those noticed will be given a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For suspected asthma population, we provide community-based spirometry PFT and education; If individuals whose FEV1 improved by ≥12% and ≥200 mL, they will be undiagnosed asthma patients and encouraged to seek treatment to the superior hospitals. 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 for those with abnormal blood pressure and glucose. Intensive follow-ups will be conducted at month 3, 6, 12.
Receives: Combination Product: Multi-component Intervention Package
Control ArmNo interventionThose who are assigned in the control arm, we will ask them to finish the same ECRHS asthma screening online questionnaire with notification of his or her suspected asthma status and a face-to-face survey. No physical examinations, community-based pulmonary function tests will be given.

What is being measured

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

  1. Number of Chronic Diseases Controlled

    Among all objectively measured diseases (asthma, COPD, BMI, hypertensions, type 2 diabetes, depression symptoms, anxiety symptoms), the number of chronic diseases controlled defined by objective measurement at month 12.

    Measured: 1 year

  2. Lung function testing

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

    Measured: 1 year

  3. ACT score

    Definition: Asthma Control Test score Variable type: Continuous; Measurement: Respondent's answer to the question; Introduction to ACT score: Asthma control test (ACT), ranging from 0 to 25, the lower the score, the better asthma controlled.

    Measured: 1 year

Secondary outcomes (39)
  1. Self-rated 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. Asthma Knowledge

    Definition: The first 7 questions within Chinese version Patient Asthma Knowledge Questionnaire, the higher the score, the more correct statements the respondents will have chosen.

    Variable type: Continuous; Measurement: Respondent's answer to the question;

    Measured: 1 year

  3. Bronchial Asthma Screening

    Definition: Have you ever been screened for bronchial asthma by a doctor? Variable type: Binary; Measurement: Respondent's answer to the question;

    Measured: 1 year

  4. Bronchial Asthma Diagnosis

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

    Measured: 1 year

  5. Bronchial Asthma Treatment

    Definition: Have you followed the treatment therapy from the professional physicians for asthma? Variable Type: Binary; Measurement: Respondent's answer to the question;

    Measured: 1 year

  6. Bronchial Asthma Control

    Definition: ACT score to categorize whether controlled or not Variable Type: Binary; Measurement: Respondent's answer to the question;

    Measured: 1 year

  7. Blood pressure

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

    Measured: 1 year

  8. 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

  9. Waist circumference

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

    Measured: 1 year

  10. BMI

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

    Measured: 1 year

  11. Number of Outpatient Visits

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

    Measured: 1 year

  12. Number of Inpatient Visits

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

    Measured: 1 year

  13. Medical expenditure within a family over the past year

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

    Measured: 1 year

  14. 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

  15. 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

  16. 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.

    Measured: 1 year

  17. Family level annual consumption expenditure

    Definition: Annual total household expenditure Variable type: Categorical Measurement: Answer to a question covering local expenditure categories by the household representative

    Measured: 1 year

  18. Employment status

    Definition: Main occupation and type; Variable type: Categorical; Measurement: Respondent's answer to the question;

    Measured: 1 year

  19. Productivity Loss

    Definition: Productivity loss due to illness or health problems from Working Productivity and Activity Impairment-General Health Chinese version 2.0; Variable type: Continuous; Measurement: Respondent's answer to the question;

    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

  20. FEV1 measurement

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

    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. Smoking Amount

    Definition: How many cigarettes do you smoke per day on average? Variable type: Count; Measurement: Respondent's answer to the question;

    Measured: 1 year

  31. 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

  32. Sugar Consumption

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

    Measured: 1 year

  33. Salted Vegetables Consumption

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

    Measured: 1 year

  34. Vegetable Consumption

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

    Measured: 1 year

  35. Physical exercise

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

    Measured: 1 year

  36. 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

  37. COPD-Knowledge

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

    Measured: 1 year

  38. mMRC score

    Definition: score for mMRC questionnaire Variable type: Categorical Measurement: Respondent's answers 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.

    Measured: 1 year

  39. 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.

    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
9,194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06457009
Sponsor's protocol ID
CAMS&PUMC-IEC-2024-041
Acronym
POPMIX-Asthma
Status last verified
Apr 2026
First submitted
7 Jun 2024
Last updated
4 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Huang K, Tong X, Tang X, Lai Q, Liu Y, Zhang S, Zheng Z, Chen W, Cao Z, Tang L, Zhao J, He L, Jiao L, Wang Y, Zhao T, Luo Y, Lyu X, Chen Q, Vollmer S, Geldsetzer P, Jamison D, Barnighausen T, Chen S, Wang C, Yang T; POPMIX study investigators. Impact of the POPulation Medicine Multimorbidity Intervention in Xishui County (POPMIX) on suspected asthma patients: protocol for the POPMIX-Asthma cluster-randomized controlled trial. Trials. 2026 Apr 11;27(1):301. doi: 10.1186/s13063-026-09685-5.

    PubMed 41964072

Questions about this trial

What is this clinical trial studying?

A study testing Multi-component Intervention Package in people with Multimorbidity and Chronic Asthma, 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 2 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?

Number of Chronic Diseases Controlled (time frame: 1 year). The study lists 3 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 NCT06457009, 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.

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