Xishui Project for IDM of COPD and Comorbidities
- Conditions
- Comorbidities and Coexisting ConditionsChronic Obstructive Pulmonary Disease
- Interventions
- Combination Product: Integrated Disease Management
- Registration Number
- NCT06456749
- Lead Sponsor
- China-Japan Friendship Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 4000
- Aged ≥40 years;
- Stable COPD patients with post-bronchodilator FEV1/FVC <70% or previously diagnosed of COPD by physicians and confirmed by PFT;
- With/without diabetes and/or hypertension;
- Permanent resident of Xishui (not expected to leave the area within 1 year).
- Suffering from severe cognitive disorders or total loss of ability of daily living.
- Death.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COPD patients with comorbidities Integrated Disease Management Adult patients diagnosed of stable COPD with/without diabetes and/or hypertension.4000 stable COPD patients, and among them approximately 2000 subjects with hypertension and/or type 2 diabetes complications.
- Primary Outcome Measures
Name Time Method FEV1 values baseline, 24 weeks 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;
Change from baseline in FEV1 values at week 24 24 weeks 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;
- Secondary Outcome Measures
Name Time Method Medical expenditure 48 weeks Definition: Expenditure related to healthcare Functional form: Continuous Measurement: Medical records + additional indirect expenditures recalled from questions
Smoking Status 48 weeks Definition: Do you currently smoke? Functional form: Binary/Continuous Measurement: Recall question answered by individual
Smoking Amount 48 weeks Definition: If so, how many cigarettes do you smoke per day Functional form: Count Measurement: Recall question answered by individual
Fresh Vegetable Consumption 48 weeks Definition: Habit of fresh vegetables consumption Functional form: Categorical Measurement: Recall question answered by individual
Saint George Respiratory Questionnaire Score 48 weeks The overall evaluation of SGRQ score
Actual implementation of IDM 48 weeks Actual implementation of IDM (e.g. clinical visit frequency, treatment adherence, etc.,) of over all patients, and stratified by type of comorbidities.
Hospitalization 48 weeks Definition: Hospitalization during the study period (by hospital types) Functional form: Count Measurement: Medical records
Blood pressure 48 weeks Definition: Systolic and diastolic blood pressure (mmHg) Functional form: Continuous Measurement: Omron portable automated sphygmomanometers
Physical exercise 48 weeks Definition: Types of physical exercise in a typical week Functional form: Categorical Measurement: Recall question answered by individual
Blood Glucose 48 weeks Definition: glucose level in plasma Functional form: Continuous Measurement: Blood glucose meters
Body mass index 48 weeks Definition: Body mass divided by the square of the body height (kg/m2) Functional form: Continuous Measurement: Calculation
COPD disease outcomes 48 weeks COPD disease outcomes (Life expectancy/Quality of Life/exacerbation/ mortality etc.) within week 48 and stratified by type of comorbidities.
Outpatient 48 weeks Definition: Clinic or emergency utilization during the study period Functional form: Count Measurement: Medical records
Waist circumference 48 weeks Definition: Waist circumference (cm) Functional form: Continuous Measurement: Soft tape measure
Alcohol 48 weeks Definition: Frequency of alcohol consumption in the past 3 months Functional form: Categorical Measurement: Recall question answered by individual
Salted Vegetable Consumption 48 weeks Definition: Habit of salted vegetable consumption Functional form: Categorical Measurement: Recall question answered by individual
Productivity Loss 48 weeks 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)
Quality of life (by EQ-5D-5L) 48 weeks Definition: General self-rated health status Functional form: Continuous Measurement: EQ-5D instrument
Sugared consumption 48 weeks Definition: Habit of sugared drink consumption Functional form: Categorical Measurement: Recall question answered by individual
Household consumption expenditures 48 weeks Definition: Total household annual expenditure Functional form: Continuous Measurement: A comprehensive spectrum of expenditure categories answered by household proxy respondent
Working status 48 weeks Definition: Main occupation and type Functional form: Categorical Measurement: Recall question answered by individual