Impact of Multi-Component Interventions on High Risk COPD Population
- Conditions
- Chronic Obstructive Pulmonary DiseaseMultimorbidityPopulation Medicine
- Interventions
- Combination Product: Multi-component intervention package
- Registration Number
- NCT06456996
- Lead Sponsor
- Peking Union Medical College
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 7400
- 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.
- Pregnancy and other conditions that are not allowed to finish pulmonary function tests;
- Severe cognitive disorder or total loss of capability of daily living
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention arm Multi-component intervention package Within the intervention arm, all medical practitioners will be under a pay-for-population mechanism to incentivize them to care for the overall population health within their township. 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.
- Primary Outcome Measures
Name Time Method Lung function testing 1 year Definition: Have you ever had a pulmonary function test?; Variable type: Binary; Measurement: Respondent's answer to the question;
FEV1 measurement 1 year Definition: Forced Expiratory Volume in one second (FEV1); Variable type: Continuous; Measurement: Pulmonary function test, portable spirometry;
Number of Chronic Diseases Controlled 1 year 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.
- Secondary Outcome Measures
Name Time Method Employment status 1 year Definition: Main occupation and type; Variable type: Categorical; Measurement: Respondent's answer to the question;
HBP Screening 1 year 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;
HBP Diagnosis 1 year Definition: Have you ever been diagnosed with hypertension by a doctor?; Variable type: Binary; Measurement: Respondent's answer to the question;
HBP Treatment 1 year 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;
HBP Control 1 year Definition: Blood pressure within the normal range at the end-of-year follow-up; Variable type: Binary; Measurement: Blood pressure measurement;
T2DM Screening 1 year 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;
T2DM Diagnosis 1 year Definition: Have you ever been diagnosed with T2DM by a doctor?; Variable type: Binary; Measurement: Respondent's answer to the question;
T2DM Treatment 1 year 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;
T2DM Control 1 year Definition: Blood glucose within the normal range at the end-of-year follow-up; Variable type: Binary; Measurement: Blood glucose measurement;
Smoking status 1 year Definition: Do you currently smoke? Variable type: Binary/Categorical; Measurement: Respondent's answer to the question;
Smoking Amount 1 year Definition: How many cigarettes do you smoke per day on average?; Variable type: Count; Measurement: Respondent's answer to the question;
Drinking Status 1 year Definition: Frequency of alcohol consumption in the past 3 months; Variable type: Categorical; Measurement: Respondent's answer to the question;
Sugar Consumption 1 year Definition: Frequency of consumption of sugary foods/drinks; Variable type: Categorical; Measurement: Respondent's answer to the question;
Salted Vegetables Consumption 1 year Definition: Frequency of consumption of salty vegetables; Variable type: Categorical; Measurement: Respondent's answer to the question;
Vegetable Consumption 1 year Definition: Frequency of consumption of vegetable; Variable type: Categorical; Measurement: Respondent's answer to the question;
Physical exercise 1 year Definition: Hours of physical exercise per week; Variable type: Count; Measurement: Respondent's answer to the question;
Asthma knowledge 1 year 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.
Saint George Respiratory Questionnaire score 1 year 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.
ACT score 1 year 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
Asthma diagnosis 1 year Definition: Have you ever diagnosed as asthma patient by professional physician? Variable type: Binary; Measurement: Respondent's answer to the question;
Smoking dependence 1 year 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.
Number of inpatient visits 1 year Definition: Inpatient visits and type of hospital; Variable type: Count; Measurement: Insurance/inpatient data/survey data
Medical expenditure within a family over the past year 1 year Definition: Healthcare-related expenditures; Variable type: Continuous; Measurement: Survey data/insurance/outpatient/inpatient data;
Self-rated health status 1 year 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
COPD knowledge 1 year 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.
Self-awareness of COPD 1 year Definition: Have you ever been diagnosed with COPD?; Variable type: Binary; Measurement: Respondent's answer to the question;
COPD treatment adherence 1 year 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;
COPD control 1 year Definition: Has the number of acute exacerbations decreased in the past six months?; Variable type: Binary; Measurement: Respondent's answer to the question;
CAT score 1 year 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.
mMRC score 1 year 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.
Number of outpatient visits 1 year Definition: Outpatient visits and type of hospital; Variable type: Count; Measurement: Insurance/outpatient data/survey data
Depression Symptoms 1 year 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.
Anxiety Symptoms 1 year 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.
Warwick-Edinburgh Mental Well-being Scale, WEM -WBS score 1 year 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.
Blood pressure 1 year Definition: Systolic and diastolic blood pressure (mmHg); Variable type: Continuous; Measurement: Omron portable automatic blood pressure monitor;
Blood Glucose 1 year Definition: Reference standard for average plasma glucose concentration over a period of time; Variable type: Continuous; Measurement: Blood glucose meter;
Waist circumference 1 year Definition: Waist circumference (cm); Variable type: Continuous; Measurement: Soft measuring tape;
BMI 1 year Definition: Body mass index (BMI), weight divided by height squared (kg/m²); Variable type: Continuous; Measurement: Calculation;
Family level annual consumption expenditure 1 year 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;
Productivity loss 1 year 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:
1. = currently employed
2. = hours missed due to health problems
3. = hours missed other reasons
4. = hours actually worked
5. = degree health affected productivity while working
6. = 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
Trial Locations
- Locations (1)
26 township hospitals in Xishui County
🇨🇳Zunyi, Guizhou, China