Chronic Obstructive Pulmonary Disease, Comorbidities and Coexisting Conditions
Conditions
Keywords
Effectiveness of Integrated Disease Management, Multimorbidity Management, Prosepective Cohort Study
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.
Interventions
COMBINATION_PRODUCTIntegrated Disease Management
For COPD, they are encouraged to seek further cares and manage COPD on a regular basis. For smokers, they will be given a digital health intervention based on CBT. For participants with symptoms of depression or anxiety, another digital health intervention is provided. For abnormal BMI participants, a knowledge brochure will be provided and a medical worker from the township hospital will tell the harm of abnormal BMI. For hypertension and type 2 diabetes, we will actively include them into the National Essential Public Health program.
Sponsors
Peking Union Medical College
Heidelberg University
China-Japan Friendship Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* Suffering from severe cognitive disorders or total loss of ability of daily living. * Death.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Outpatient | 48 weeks | Definition: Clinic or emergency utilization during the study period Functional form: Count Measurement: Medical records |
| Hospitalization | 48 weeks | Definition: Hospitalization during the study period (by hospital types) Functional form: Count Measurement: Medical records |
| Medical expenditure | 48 weeks | Definition: Expenditure related to healthcare Functional form: Continuous Measurement: Medical records + additional indirect expenditures recalled from questions |
| Quality of life (by EQ-5D-5L) | 48 weeks | Definition: General self-rated health status Functional form: Continuous Measurement: EQ-5D instrument |
| Blood pressure | 48 weeks | Definition: Systolic and diastolic blood pressure (mmHg) Functional form: Continuous Measurement: Omron portable automated sphygmomanometers |
| Waist circumference | 48 weeks | Definition: Waist circumference (cm) Functional form: Continuous Measurement: Soft tape measure |
| 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 |
| Smoking Status | 48 weeks | Definition: Do you currently smoke? Functional form: Binary/Continuous Measurement: Recall question answered by individual |
| 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. |
| Alcohol | 48 weeks | Definition: Frequency of alcohol consumption in the past 3 months Functional form: Categorical Measurement: Recall question answered by individual |
| Sugared consumption | 48 weeks | Definition: Habit of sugared drink consumption Functional form: Categorical 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 |
| Salted Vegetable Consumption | 48 weeks | Definition: Habit of salted vegetable consumption Functional form: Categorical Measurement: Recall question answered by individual |
| Physical exercise | 48 weeks | Definition: Types of physical exercise in a typical week 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) |
| 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 |
| Saint George Respiratory Questionnaire Score | 48 weeks | The overall evaluation of SGRQ score |
| Smoking Amount | 48 weeks | Definition: If so, how many cigarettes do you smoke per day Functional form: Count Measurement: Recall question answered by individual |
| 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. |
Contacts
Primary ContactTing Yang, MD
Backup ContactYuhao Liu, PhD student
Outcome results
None listed