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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06458218
Other study ID # CAMS&PUMC-IEC-2024-043
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
Study type Interventional

Clinical 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 . 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. 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.


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 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. Exclusion Criteria: - Those who suffer from severe cognitive disorder or total loss of ability of daily living.

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Multi-component Interventions
Community-based spirometry pulmonary function tests and result interpretations and health education for COPD; A digital health intervention program, EmoEase, for individuals with mental health issues among high-risk COPD population(very familiar with intelligent mobile phone); NicQuit, digital health intervention to smokers; Health education to smokers and 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 pressure and glucose are higher than the normal value into the National Essential Public Health Service in China; A CBT-based health education to the BMI abnormal; Pay-for-performance incentives to medical workers.

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 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
Primary 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
Primary 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 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. 1 year
Secondary 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. 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 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 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 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 Outpatient Definition: Outpatient visits and type of hospital; Variable type: Count; Measurement: Insurance/outpatient data; 1 year
Secondary Inpatient Definition: Inpatient visits and type of hospital; Variable type: Count; Measurement: Insurance/outpatient 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 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:
= 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 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; 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 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
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