Impact of Multi-Component Interventions on High Risk COPD Population

Chronic Obstructive Pulmonary Disease Clinical Trial

— POPMIX-COPD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06456996
• Other study ID #: CAMS&PUMC-IEC-2024-040
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 17, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: June 2024
• Source: Peking Union Medical College
• Contact: Simiao Chen, Ph.D.
• Phone: 010-65104915
• Email: simiao.chen[@]uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 7400
• Est. completion date: October 1, 2025
• Est. primary completion date: September 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• Aged 35 and above;

• COPD-SQ score is 16 and above;

• 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.

Exclusion Criteria:

• Pregnancy and other conditions that are not allowed to finish pulmonary function tests;

• Severe cognitive disorder or total loss of capability of daily living

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Multimorbidity
• Pulmonary Disease, Chronic Obstructive

Intervention

Combination Product:
• Multi-component intervention package
Community-based spirometry pulmonary function tests and result interpretations and health education for COPD; A digital health intervention program, NicQuit, for smokers(very familiar with intelligent mobile phone); A digital health intervention program, EmoEase, for individuals whose WEMWBS questionnaire score is lower than 45(very familiar with intelligent mobile phone); Health education to smokers for smoking cessation; Health education to individuals with mental health issues; Encouragement to seek professional medication treatment in superior hospitals for spirometry-defined COPD patients; To actively include individuals whose blood pressurei 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; 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College	China-Japan Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Lung function testing	Definition: Have you ever had a pulmonary function test?; Variable type: Binary; Measurement: Respondent's answer to the question;	1 year
Primary	FEV1 measurement	Definition: Forced Expiratory Volume in one second (FEV1); Variable type: Continuous; Measurement: Pulmonary function test, portable spirometry;	1 year
Secondary	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
Secondary	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
Secondary	Self-awareness of COPD	Definition: Have you ever been diagnosed with COPD?; Variable type: Binary; Measurement: Respondent's answer to the question;	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of outpatient visits	Definition: Outpatient visits and type of hospital; Variable type: Count; Measurement: Insurance/outpatient data	1 year
Secondary	Number of inpatient visits	Definition: Inpatient visits and type of hospital; Variable type: Count; Measurement: Insurance/inpatient data	1 year
Secondary	Medical expenditure within a family over the past year	Definition: Healthcare-related expenditures; Variable type: Continuous; Measurement: Insurance/outpatient/inpatient data;	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood pressure	Definition: Systolic and diastolic blood pressure (mmHg); Variable type: Continuous; Measurement: Omron portable automatic blood pressure monitor;	1 year
Secondary	Blood Glucose	Definition: Reference standard for average plasma glucose concentration over a period of time; Variable type: Continuous; Measurement: Blood glucose meter;	1 year
Secondary	Waist circumference	Definition: Waist circumference (cm); Variable type: Continuous; Measurement: Soft measuring tape;	1 year
Secondary	BMI	Definition: Body mass index (BMI), weight divided by height squared (kg/m²); Variable type: Continuous; Measurement: Calculation;	1 year
Secondary	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
Secondary	Employment status	Definition: Main occupation and type; Variable type: Categorical; Measurement: Respondent's answer to the question;	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Smoking status	Definition: Do you currently smoke? Variable type: Binary/Categorical; Measurement: Respondent's answer to the question;	1 year
Secondary	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
Secondary	Drinking Status	Definition: Frequency of alcohol consumption in the past 3 months; Variable type: Categorical; Measurement: Respondent's answer to the question;	1 year
Secondary	Sugar Consumption	Definition: Frequency of consumption of sugary foods/drinks; Variable type: Categorical; Measurement: Respondent's answer to the question;	1 year
Secondary	Salted Vegetables Consumption	Definition: Frequency of consumption of salty vegetables; Variable type: Categorical; Measurement: Respondent's answer to the question;	1 year
Secondary	Vegetable Consumption	Definition: Frequency of consumption of vegetable; Variable type: Categorical; Measurement: Respondent's answer to the question;	1 year
Secondary	Physical exercise	Definition: Hours of physical exercise per week; Variable type: Count; Measurement: Respondent's answer to the question;	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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: = 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	1 year