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

Tobacco Use Cessation Clinical Trial

— POPMIX-Smoking  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458205
• Other study ID #: CAMS&PUMC-IEC-2024-042
• 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: 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. 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.

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;
• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Multimorbidity
• Smoking Reduction
• Tobacco Use Cessation

Intervention

Combination Product:
• Multi-component intervention for smokers
Community-based spirometry pulmonary function tests and result interpretations and health education; A digital health intervention program, NicQuit, for smokers(very familiar with intelligent mobile phone); A digital health intervention program, EmoEase, for smokers whose WEMWBS questionnaire score is lower than 45(very familiar with intelligent mobile phone); Health education to smokers for smoking cessation; Health education to smokers with mental health issues; Encouragement to seek professional medication treatment in superior hospitals for spirometry-defined COPD patients or asthma patients; 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; 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	Amount of smoking	Definition: Average number of cigarettes smoked per day; Variable type: Continuous; Measurement: Respondent's answer to the question.	1 year
Primary	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 15, 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	1 year
Primary	Carbon Monoxide Measurement	Definition: CO measurement by the portable CO machines Variable type: Continuous; Measurement: CO detector.	1 year
Secondary	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.	1 year
Secondary	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;	1 year
Secondary	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.	1 year
Secondary	FEV1 measurement	Definition: Forced Expiratory Volume in one second (FEV1); Variable type: Continuous; Measurement: Pulmonary function test, portable spirometry;	1 year
Secondary	COPD Screening	Definition: Have you ever had a pulmonary function test?; Variable type: Binary; Measurement: Respondent's answer to the question;	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-Knowledge	Definition: COPD Knowledge Questionnaire; Variable type: Continuous; Measurement: Respondent's answer to the questions;	1 year
Secondary	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	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	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	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	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: = 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
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; 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