Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT06458218
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-30
First Post:
2024-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Multi-component Interventions on Populations with Mental Health Symptoms and High-risk COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7400}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2024-06-09', 'studyFirstSubmitQcDate': '2024-06-09', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression Symptoms', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'Anxiety Symptoms', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'Warwick-Edinburgh Mental Well-being Scale, WEM -WBS', 'timeFrame': '1 year', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Number of chronic diseases controlled', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'Self-rated health status', 'timeFrame': '1 year', 'description': "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."}, {'measure': 'FEV1 measurement', 'timeFrame': '1 year', 'description': 'Definition: Forced Expiratory Volume in one second (FEV1); Variable type: Continuous; Measurement: Pulmonary function test, portable spirometry;'}, {'measure': 'mMRC score', 'timeFrame': '1 year', 'description': "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."}, {'measure': 'CAT score', 'timeFrame': '1 year', 'description': "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."}, {'measure': 'COPD Screening', 'timeFrame': '1 year', 'description': "Definition: Have you ever had a pulmonary function test?; Variable type: Binary; Measurement: Respondent's answer to the question;"}, {'measure': 'Self-awareness of COPD', 'timeFrame': '1 year', 'description': "Definition: Have you ever been diagnosed with COPD?; Variable type: Binary; Measurement: Respondent's answer to the question;"}, {'measure': 'COPD-Knowledge', 'timeFrame': '1 year', 'description': "Definition: COPD Knowledge Questionnaire; Variable type: Continuous; Measurement: Respondent's answer to the questions;"}, {'measure': 'Treatment adherence', 'timeFrame': '1 year', 'description': "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;"}, {'measure': 'COPD control', 'timeFrame': '1 year', 'description': "Definition: Has the number of acute exacerbations decreased in the past six months?; Variable type: Binary; Measurement: Respondent's answer to the question;"}, {'measure': 'Blood pressure', 'timeFrame': '1 year', 'description': 'Definition: Systolic and diastolic blood pressure (mmHg); Variable type: Continuous; Measurement: Omron portable automatic blood pressure monitor;'}, {'measure': 'Blood Glucose', 'timeFrame': '1 year', 'description': 'Definition: Reference standard for average plasma glucose concentration over a period of time; Variable type: Continuous; Measurement: Blood glucose meter;'}, {'measure': 'Waist circumference', 'timeFrame': '1 year', 'description': 'Definition: Waist circumference (cm); Variable type: Continuous; Measurement: Soft measuring tape;'}, {'measure': 'BMI', 'timeFrame': '1 year', 'description': 'Definition: Body mass index (BMI), weight divided by height squared (kg/m²); Variable type: Continuous; Measurement: Calculation;'}, {'measure': 'Outpatient', 'timeFrame': '1 year', 'description': 'Definition: Outpatient visits and type of hospital; Variable type: Count; Measurement: Survey data/insurance/outpatient data;'}, {'measure': 'Inpatient', 'timeFrame': '1 year', 'description': 'Definition: Inpatient visits and type of hospital; Variable type: Count; Measurement: Survey data/insurance/outpatient data;'}, {'measure': 'Medical expenditure within a family over the past year', 'timeFrame': '1 year', 'description': 'Definition: Healthcare-related expenditures; Variable type: Continuous; Measurement: Survey data/insurance/outpatient/inpatient data;'}, {'measure': 'Productivity Loss', 'timeFrame': '1 year', 'description': "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;\n\nWPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, as follows:\n\nQuestions:\n\n1. = currently employed\n2. = hours missed due to health problems\n3. = hours missed other reasons\n4. = hours actually worked\n5. = degree health affected productivity while working\n6. = degree health affected regular activities\n\nScores:\n\nMultiply scores by 100 to express in percentages.\n\nPercent work time missed due to health: Q2/(Q2+Q4)\n\nPercent impairment while working due to health: Q5/10\n\nPercent overall work impairment due to health:\n\nQ2/(Q2+Q4)+\\[(1-(Q2/(Q2+Q4)))x(Q5/10)\\]\n\nPercent activity impairment due to health: Q6/10"}, {'measure': 'HBP Screening', 'timeFrame': '1 year', 'description': "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;"}, {'measure': 'HBP Diagnosis', 'timeFrame': '1 year', 'description': "Definition: Have you ever been diagnosed with hypertension by a doctor?; Variable type: Binary; Measurement: Respondent's answer to the question;"}, {'measure': 'HBP Treatment', 'timeFrame': '1 year', 'description': "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;"}, {'measure': 'HBP Control', 'timeFrame': '1 year', 'description': 'Definition: Blood pressure within the normal range at the end-of-year follow-up; Variable type: Binary; Measurement: Blood pressure measurement'}, {'measure': 'T2DM Screening', 'timeFrame': '1 year', 'description': "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;"}, {'measure': 'T2DM Diagnosis', 'timeFrame': '1 year', 'description': "Definition: Have you ever been diagnosed with T2DM by a doctor?; Variable type: Binary; Measurement: Respondent's answer to the question;"}, {'measure': 'T2DM Treatment', 'timeFrame': '1 year', 'description': "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;"}, {'measure': 'T2DM Control', 'timeFrame': '1 year', 'description': 'Definition: Blood glucose within the normal range at the end-of-year follow-up; Variable type: Binary; Measurement: Blood glucose measurement;'}, {'measure': 'Smoking Status', 'timeFrame': '1 year', 'description': "Definition: Do you currently smoke?; Variable type: Binary; Measurement: Respondent's answer to the question;"}, {'measure': 'Smoking Amount', 'timeFrame': '1 year', 'description': "Definition: If yes, how many cigarettes do you smoke per day on average?; Variable type: Count; Measurement: Respondent's answer to the question;"}, {'measure': 'Drinking Status', 'timeFrame': '1 year', 'description': "Definition: Frequency of alcohol consumption in the past 3 months; Variable type: Categorical; Measurement: Respondent's answer to the question;"}, {'measure': 'Sugar Consumption', 'timeFrame': '1 year', 'description': "Definition: Frequency of consumption of sugary foods/drinks; Variable type: Categorical; Measurement: Respondent's answer to the question;"}, {'measure': 'Salted Vegetables Consumption', 'timeFrame': '1 year', 'description': "Definition: Frequency of consumption of salty vegetables; Variable type: Categorical; Measurement: Respondent's answer to the question;"}, {'measure': 'Vegetable Consumption', 'timeFrame': '1 year', 'description': "Definition: Frequency of consumption of vegetable; Variable type: Categorical; Measurement: Respondent's answer to the question;"}, {'measure': 'Physical exercise', 'timeFrame': '1 year', 'description': "Definition: Hours of physical exercise per week; Variable type: Count; Measurement: Respondent's answer to the question;"}, {'measure': 'Smoking Dependence', 'timeFrame': '1 year', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multimorbidity', 'Mental Health Issue', 'Multi-component Interventions']}, 'descriptionModule': {'briefSummary': '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 .\n\nIntervention: 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.\n\nComparison: 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.\n\nOutcomes: The primary outcomes are PHQ-9 scores for depression symptoms, GAD-7 symptoms for anxiety symptoms, and WEM-WBS score at month 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 35 and above;\n* High-risk COPD population, defined by score of COPD-SQ ≥ 16;\n* Mental health issues, defined by WEM-WBS scale \\< 45;\n* 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.\n\nExclusion Criteria:\n\n* Those who suffer from severe cognitive disorder or total loss of ability of daily living.'}, 'identificationModule': {'nctId': 'NCT06458218', 'acronym': 'POPMIX-MH', 'briefTitle': 'Impact of Multi-component Interventions on Populations with Mental Health Symptoms and High-risk COPD', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College'}, 'officialTitle': 'Population Medicine Multimorbidity Interventions in Xishui on a High-Risk COPD Population with Mental Health Symptoms: a Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CAMS&PUMC-IEC-2024-043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'We have constructed a pay-for-population mechanism to encourage medical workers caring for population health. We will ask study populations to finish online COPD-SQ questionnaire with notification of his or her COPD high risk status. For high-risk COPD population, we will provide a face-to-face survey and examination, and provide a multi-component intervention at baseline. We give community-based spirometry pulmonary function test and education; If individuals who are COPD patients, they will be encouraged to seek treatment to the superior hospitals. A CBT-based digital health program will be provided. Also health education will be given. Additionally, we provide (1) a digital health intervention programs to smokers; (2) CBT-based health education for the abnormal BMI; (3) active recruitment into National Essential Public Health Program for those with high blood pressure and blood glucose. Intensive follow-ups will be conducted at month 3, 6, 12.', 'interventionNames': ['Combination Product: Multi-component Interventions']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': '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.'}], 'interventions': [{'name': 'Multi-component Interventions', 'type': 'COMBINATION_PRODUCT', 'description': '1. Community-based spirometry pulmonary function tests and result interpretations and health education for COPD;\n2. A digital health intervention program, EmoEase, for individuals with mental health issues among high-risk COPD population(very familiar with intelligent mobile phone);\n3. NicQuit, digital health intervention to smokers;\n4. Health education to smokers and individuals with mental health issues;\n5. Encouragement to seek professional medication treatment in superior hospitals for spirometry-defined COPD patients;\n6. To actively include individuals whose blood pressure and glucose are higher than the normal value into the National Essential Public Health Service in China;\n7. A CBT-based health education to the BMI abnormal;\n8. Pay-for-performance incentives to medical workers.', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zunyi', 'state': 'Guizhou', 'country': 'China', 'facility': 'Xishui County', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}], 'overallOfficials': [{'name': 'Simiao Chen, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College', 'class': 'OTHER'}, 'collaborators': [{'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Simiao Chen', 'investigatorAffiliation': 'Peking Union Medical College'}}}}