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MultimorbidityPOPMIX-MHNCT06458218

Impact of Multi-component Interventions on Populations With Mental Health Symptoms and High-risk COPD

A study testing Multi-component Interventions in people with Multimorbidity and Mental Health Issue, 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: High-risk COPD population with mental health symptoms, defined as individuals whose score of COPD-SQ ≥ 16, whose age is 35 and above, and whose Warwick-Edinburgh Mental Well-being Scale <45 . Read more about this study

Who is it for?
Ages 35 years and older
What is being tested?
Multi-component Interventions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,571 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 score of COPD-SQ ≥ 16;
  • Mental health issues, defined by WEM-WBS scale < 45;
  • 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

    Zunyi, Guizhou

Other trials in China

About this study

Official title: Population Medicine Multimorbidity Interventions in Xishui on a High-Risk COPD Population With Mental Health Symptoms: A Cluster Randomized Controlled Trial

Study Participants: High-risk COPD population with mental health symptoms, defined as individuals whose score of COPD-SQ ≥ 16, whose age is 35 and above, and whose Warwick-Edinburgh Mental Well-being Scale <45 .

Intervention: We have constructed a pay-for-population mechanism for medical practitioners within the intervention townships to encourage them caring 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. For those with high-risk COPD population, we will provide face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For high-risk COPD population with mental health issues 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. A CBT-based digital health intervention program, EmoEase, will be provided to our study participants with an intelligent mobile phone. Also health education in terms of mental health issues will be given. Additionally, we provide (1) a digital health intervention programs to smokers; (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 PHQ-9 scores for depression symptoms, GAD-7 symptoms for anxiety symptoms, and WEM-WBS score at month 12.

Being tested
Multi-component Interventions

What participants receive

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

  • Multi-component InterventionsCombination product

    1. Community-based spirometry pulmonary function tests and result interpretations and health education for COPD;
    2. A digital health intervention program, EmoEase, for individuals with mental health issues among high-risk COPD population(very familiar with intelligent mobile phone);
    3. NicQuit, digital health intervention to smokers;
    4. Health education to smokers and individuals with mental health issues;
    5. Encouragement to seek professional medication treatment in superior hospitals for spirometry-defined COPD patients;
    6. To actively include individuals whose blood pressure and glucose are higher than the normal value into the National Essential Public Health Service in China;
    7. A CBT-based health education to the BMI abnormal;
    8. Pay-for-performance incentives to medical workers.
Study groups in NCT06458218
Study groupRoleWhat they receive
Intervention armExperimentalWe have constructed a pay-for-population mechanism to encourage medical workers caring for population health. We will ask study populations to finish online COPD-SQ questionnaire with notification of his or her COPD high risk status. For high-risk COPD population, we will provide a face-to-face survey and examination, and provide a multi-component intervention at baseline. We give community-based spirometry pulmonary function test and education; If individuals who are COPD patients, they will be encouraged to seek treatment to the superior hospitals. A CBT-based digital health program will be provided. Also health education will be given. Additionally, we provide (1) a digital health intervention programs to smokers; (2) CBT-based health education for the abnormal BMI; (3) active recruitment into National Essential Public Health Program for those with high blood pressure and blood glucose. Intensive follow-ups will be conducted at month 3, 6, 12.
Receives: Combination Product: Multi-component Interventions
Control ArmNo interventionThose 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.

What is being measured

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

  1. 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

  2. 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

  3. 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

Secondary outcomes (34)
  1. Number of chronic diseases controlled

    Definition: Among all 7 objectively measured health conditions (depression symptoms, anxiety symptoms, COPD, asthma, BMI, hypertension, type 2 diabetes), number of chronic diseases controlled; Variable type: Counting data; Measurement: Physical examination or validated scales.

    Measured: 1 year

  2. 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

  3. FEV1 measurement

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

    Measured: 1 year

  4. 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.

    Measured: 1 year

  5. 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.

    Measured: 1 year

  6. COPD Screening

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

    Measured: 1 year

  7. 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

  8. COPD-Knowledge

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

    Measured: 1 year

  9. 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

  10. 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

  11. Blood pressure

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

    Measured: 1 year

  12. 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

  13. Waist circumference

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

    Measured: 1 year

  14. BMI

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

    Measured: 1 year

  15. Outpatient

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

    Measured: 1 year

  16. Inpatient

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

    Measured: 1 year

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. Smoking Status

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

    Measured: 1 year

  28. Smoking Amount

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

    Measured: 1 year

  29. 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

  30. Sugar Consumption

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

    Measured: 1 year

  31. Salted Vegetables Consumption

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

    Measured: 1 year

  32. Vegetable Consumption

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

    Measured: 1 year

  33. Physical exercise

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

    Measured: 1 year

  34. 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
3,571 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06458218
Sponsor's protocol ID
CAMS&PUMC-IEC-2024-043
Acronym
POPMIX-MH
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

  • Liu Y, Chen W, Zhang S, Wang Y, Zheng Z, Huang K, Tang X, Cao Z, Tong X, Tang L, Zhao J, He L, Jiao L, Zhao T, Luo Y, Lai Q, Lyu X, Chen Q, Bunker A, Vollmer S, Geldsetzer P, Jamison D, Barnighausen T, Yang T, Chen S, Wang C; POPMIX Group. Impact of the Population Medicine Multimorbidity Intervention in Xishui County (POPMIX) on People at High Risk for Chronic Obstructive Pulmonary Disease Who Experience Mental Health Symptoms: Protocol for the POPMIX-MH Cluster Randomized Controlled Trial. JMIR Res Protoc. 2026 Mar 6;15:e85853. doi: 10.2196/85853.

    PubMed 41791105

Questions about this trial

What is this clinical trial studying?

A study testing Multi-component Interventions in people with Multimorbidity and Mental Health Issue, 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?

Depression Symptoms (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 NCT06458218, 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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