Xishui Project for IDM of COPD and Comorbidities
NCT Number: NCT06456749
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Chronic Obstructive Pulmonary Disease|Comorbidities and Coexisting Conditions
Interventions: COMBINATION_PRODUCT: Integrated Disease Management
Sponsor: China-Japan Friendship Hospital
Collaborators: Peking Union Medical College|Heidelberg University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 4000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-17
Completion Date: 2026-03-15

Summary:
Study Population: 4000 stable COPD patients, and among them approximately 2000 subjects with hypertension and/or type 2 diabetes complications.

Design: Cohort Study Primary Objectives: The primary objective of this study is to access the effectiveness of IDM on changes in FEV1 from baseline to the 24th week visit in patients with COPD.

Statistical Analysis: We plan to compare demographic differences between groups based on whether the data conformed to normal distribution and satisfied variance chi-square, and proposed to calculate p-values using the t-test or non-parametric test for continuous data and Person's χ² or non-parametric test for categorical data. A two-sided p-value \< 0.05 is considered statistically significant.

Primary Outcome Measures: FEV1 values, FEV1 values at baseline, and at week 24 in patients with COPD and in patients with COPD without diabetes or hypertension, COPD with hypertension, COPD with diabetes, and COPD with hypertension and diabetes, respectively;, baseline, 24 weeks|Change from baseline in FEV1 values at week 24, Change from baseline in FEV1 values at week 24 in patients with COPD and in patients with COPD without diabetes or hypertension, COPD with hypertension, COPD with diabetes, and COPD with hypertension and diabetes, respectively;, 24 weeks
Secondary Outcome Measures: Actual implementation of IDM, Actual implementation of IDM (e.g. clinical visit frequency, treatment adherence, etc.,) of over all patients, and stratified by type of comorbidities., 48 weeks|COPD disease outcomes, COPD disease outcomes (Life expectancy/Quality of Life/exacerbation/ mortality etc.) within week 48 and stratified by type of comorbidities., 48 weeks|Outpatient, Definition: Clinic or emergency utilization during the study period Functional form: Count Measurement: Medical records, 48 weeks|Hospitalization, Definition: Hospitalization during the study period (by hospital types) Functional form: Count Measurement: Medical records, 48 weeks|Medical expenditure, Definition: Expenditure related to healthcare Functional form: Continuous Measurement: Medical records + additional indirect expenditures recalled from questions, 48 weeks|Quality of life (by EQ-5D-5L), Definition: General self-rated health status Functional form: Continuous Measurement: EQ-5D instrument, 48 weeks|Blood pressure, Definition: Systolic and diastolic blood pressure (mmHg) Functional form: Continuous Measurement: Omron portable automated sphygmomanometers, 48 weeks|Waist circumference, Definition: Waist circumference (cm) Functional form: Continuous Measurement: Soft tape measure, 48 weeks|Blood Glucose, Definition: glucose level in plasma Functional form: Continuous Measurement: Blood glucose meters, 48 weeks|Body mass index, Definition: Body mass divided by the square of the body height (kg/m2) Functional form: Continuous Measurement: Calculation, 48 weeks|Smoking Status, Definition: Do you currently smoke? Functional form: Binary/Continuous Measurement: Recall question answered by individual, 48 weeks|Smoking Amount, Definition: If so, how many cigarettes do you smoke per day Functional form: Count Measurement: Recall question answered by individual, 48 weeks|Alcohol, Definition: Frequency of alcohol consumption in the past 3 months Functional form: Categorical Measurement: Recall question answered by individual, 48 weeks|Sugared consumption, Definition: Habit of sugared drink consumption Functional form: Categorical Measurement: Recall question answered by individual, 48 weeks|Fresh Vegetable Consumption, Definition: Habit of fresh vegetables consumption Functional form: Categorical Measurement: Recall question answered by individual, 48 weeks|Salted Vegetable Consumption, Definition: Habit of salted vegetable consumption Functional form: Categorical Measurement: Recall question answered by individual, 48 weeks|Physical exercise, Definition: Types of physical exercise in a typical week Functional form: Categorical Measurement: Recall question answered by individual, 48 weeks|Productivity Loss, Definition: the effect of your health problems on your ability to work and perform regular activities Functional form: Continuous Measurement: Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH), 48 weeks|Household consumption expenditures, Definition: Total household annual expenditure Functional form: Continuous Measurement: A comprehensive spectrum of expenditure categories answered by household proxy respondent, 48 weeks|Working status, Definition: Main occupation and type Functional form: Categorical Measurement: Recall question answered by individual, 48 weeks|Saint George Respiratory Questionnaire Score, The overall evaluation of SGRQ score, 48 weeks