Impact of Multi-Component Interventions on High Risk COPD Population
NCT Number: NCT06456996
Acronym: POPMIX-COPD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multimorbidity|Population Medicine|Chronic Obstructive Pulmonary Disease
Interventions: COMBINATION_PRODUCT: Multi-component intervention package
Sponsor: Peking Union Medical College
Collaborators: China-Japan Friendship Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 7400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-06-17
Completion Date: 2025-10-01

Summary:
Study Participants: High-risk COPD population, defined as individuals whose score of COPD-SQ is 16 and above and whose age is 35 and above. COPD-SQ questionnaire will be assigned to a representative sample of local residents in Xishui County, and they will finish the questionnaire online through mobile phone.

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 COPD-SQ questionnaire with notification of his or her COPD high risk status. Those whose score exceeds 16 will be invited to do a face-to-face survey, simple physical examination, pulmonary function tests, and provide a multi-component intervention at baseline. For High-risk COPD population 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. 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.

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 COPD knowledge, COPD screening, and FEV1 measurement at month 12.

Primary Outcome Measures: Number of Chronic Diseases Controlled, Among all objectively measured health conditions and diseases (COPD, asthma, BMI, hypertension, Type 2 diabetes, depression symptoms, anxiety symptoms), the number of chronic diseases controlled defined by objective measurement at month 12., 1 year|Lung function testing, Definition: Have you ever had a pulmonary function test?; Variable type: Binary; Measurement: Respondent's answer to the question;, 1 year|FEV1 measurement, Definition: Forced Expiratory Volume in one second (FEV1); Variable type: Continuous; Measurement: Pulmonary function test, portable spirometry;, 1 year
Secondary Outcome Measures: Self-rated health status, Definition: General self-assessed health status; Variable type: Continuous; Measurement: EQ-5D-5L 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, 1 year|COPD knowledge, Definition: Excerpt from COPD-KQ, selecting questions that test the COPD knowledge for population; Variable type: Continuous; Measurement: COPD-KQ excerpt; Introduction to COPD-KQ excerpt: An excerpt from COPD knowledge questionnaire, which contains 9 questions which we consider could be beneficial to general population to enhance the common knowledge of COPD. Minimum value is 0 and maximum value is 9, the higher the value, the more correct statements one has chosen., 1 year|Self-awareness of COPD, Definition: Have you ever been diagnosed with COPD?; Variable type: Binary; Measurement: Respondent's answer to the question;, 1 year|COPD 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;, 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;, 1 year|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., 1 year|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., 1 year|Number of outpatient visits, Definition: Outpatient visits and type of hospital; Variable type: Count; Measurement: Insurance/outpatient data, 1 year|Number of inpatient visits, Definition: Inpatient visits and type of hospital; Variable type: Count; Measurement: Insurance/inpatient data, 1 year|Medical expenditure within a family over the past year, Definition: Healthcare-related expenditures; Variable type: Continuous; Measurement: Insurance/outpatient/inpatient data;, 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., 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., 1 year|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., 1 year|Blood pressure, Definition: Systolic and diastolic blood pressure (mmHg); Variable type: Continuous; Measurement: Omron portable automatic blood pressure monitor;, 1 year|Blood Glucose, Definition: Reference standard for average plasma glucose concentration over a period of time; Variable type: Continuous; Measurement: Blood glucose meter;, 1 year|Waist circumference, Definition: Waist circumference (cm); Variable type: Continuous; Measurement: Soft measuring tape;, 1 year|BMI, Definition: Body mass index (BMI), weight divided by height squared (kg/m²); Variable type: Continuous; Measurement: Calculation;, 1 year|Family level annual consumption expenditure, Definition: Annual total household expenditure (self-reported); Variable type: Categorical; Measurement: Answer to a series of questions covering local expenditure categories by the household representative;, 1 year|Employment status, Definition: Main occupation and type; Variable type: Categorical; Measurement: Respondent's answer to the question;, 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;, 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;, 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;, 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;, 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;, 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;, 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;, 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;, 1 year|Smoking status, Definition: Do you currently smoke? Variable type: Binary/Categorical; Measurement: Respondent's answer to the question;, 1 year|Smoking Amount, Definition: How many cigarettes do you smoke per day on average?; Variable type: Count; Measurement: Respondent's answer to the question;, 1 year|Drinking Status, Definition: Frequency of alcohol consumption in the past 3 months; Variable type: Categorical; Measurement: Respondent's answer to the question;, 1 year|Sugar Consumption, Definition: Frequency of consumption of sugary foods/drinks; Variable type: Categorical; Measurement: Respondent's answer to the question;, 1 year|Salted Vegetables Consumption, Definition: Frequency of consumption of salty vegetables; Variable type: Categorical; Measurement: Respondent's answer to the question;, 1 year|Vegetable Consumption, Definition: Frequency of consumption of vegetable; Variable type: Categorical; Measurement: Respondent's answer to the question;, 1 year|Physical exercise, Definition: Hours of physical exercise per week; Variable type: Count; Measurement: Respondent's answer to the question;, 1 year|Asthma knowledge, Excerpt of PAKQ, selecting questions that general population should know in terms of asthma, ranging from 0 to 7, the higher the score, the more correct statements the respondents has chosen., 1 year|Saint George Respiratory Questionnaire score, Definition: SGRQ questionnaire for COPD patients; Variable type: continuous Measurement: Respondent's answer to the questions; Introduction to SGRQ: Saint George Respiratory Questionnaire score, ranging from 0 to 100, where 0 represents the best possible health status and 100 represents the worst possible health status., 1 year|ACT score, Definition: Asthma control test score; Variable type: Continuous; Measurement: Respondent's answer to the questions; Introduction to ACT score: Asthma control test (ACT), ranging from 0 to 25, the lower the score, the better asthma controlled, 1 year|Asthma diagnosis, Definition: Have you ever diagnosed as asthma patient by professional physician? Variable type: Binary; Measurement: Respondent's answer to the question;, 1 year|Smoking dependence, Fagerström test for nicotine dependence (FTND) is a scale that measures the nicotine dependence of smokers, ranging from 0 to 15, 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., 1 year|Productivity loss, Working Productivity and Activity Impairment-General Health (WAPI-GH) Chinese version 2.0 is used. 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, 1 year