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

Mental Health Issue Clinical Trial

— POPMIX-MH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458218
• Other study ID #: CAMS&PUMC-IEC-2024-043
• 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 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.

Related Conditions & MeSH terms

• Mental Health Issue
• Multimorbidity

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