Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
registries, demography, therapeutics, disease management, mortality
Brief summary
The aim of this study is to provide high quality data and give a comprehensive overview of characteristics, clinical features, management and prognosis during exacerbations and stable periods among inpatients with acute exacerbation of chronic obstructive pulmonary disease in real-world China.
Detailed description
Objective: The aim of this study is to provide high quality data and give a comprehensive overview of characteristics, clinical features, management and prognosis during exacerbations and stable periods among inpatients with acute exacerbation of chronic obstructive pulmonary disease in real-world China. Eligibility Criteria: Details are shown in the Eligibility Criteria part. Procedures and Measurements: At admission, each eligible subject will be given an in-depth interview to collect the demographics, smoking history, medical history, management of disease during stable period, etc. During hospitalization, treatment and auxiliary examination results including laboratory and lung function tests will be recorded if available. To ensure the quality and uniformity of spirometry data, training on performing spirometry will be provided to each study site by professional doctors from central site. At discharge, physicians will record the discharge diagnoses and clinical outcomes including death, intensive care unit admission, chronic obstructive pulmonary disease assessment test (CAT) score and total direct cost for each participant. During follow-ups, clinical outcomes including death and exacerbation events, change of medication, new-developed complications, auxiliary examination results, and economic burden will be collected.
Interventions
None listed
Sponsors
China-Japan Friendship Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years of age * hospitalized with main diagnosis of acute exacerbation of chronic obstructive pulmonary disease (AECOPD)
Exclusion criteria
* refusing to sign informed consent forms * participating in clinical trials or intervention studies of drugs * diagnosed as active pulmonary tuberculosis, or acute left heart failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause in-hospital mortality | From date of admission to date of discharge, an expected median of 10 days | All-cause mortality during hospitalization |
| Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease within 30 days after discharge | 30 days after day of discharge | Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) within 30 days after discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease within 1 year after discharge | 1 year after day of discharge | Incidence of readmission due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) within 1 year after discharge |
| Time to the first readmission due to acute exacerbation of chronic obstructive pulmonary disease | 30 days, 1 year after day of discharge | Time to the first readmission due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) during follow-ups |
| Post-bronchodilator forced expiratory volume in one second (L) | 30 days, 1 year after day of discharge | Post-bronchodilator forced expiratory volume in one second (L) during follow-ups |
| Predicted post-bronchodilator forced expiratory volume in one second (%) | 30 days, 1 year after day of discharge | Predicted post-bronchodilator forced expiratory volume in one second (%) during follow-ups |
| Post-bronchodilator forced vital capacity (L) | 30 days, 1 year after day of discharge | Post-bronchodilator forced vital capacity (L) during follow-ups |
| Chronic obstructive pulmonary disease assessment test (CAT) score | At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge | Chronic obstructive pulmonary disease assessment test (CAT) score at day of discharge and during follow-ups. CAT is an 8-item questionnaire used to measure the impact of respiratory disease on patients' health status. The score of CAT ranges from 0 to 40, with 0 indicating the best health status while 40 as the worst. |
| Modified medical research council (mMRC) dyspnea scale | At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge | Modified medical research council (mMRC) dyspnea scale at day of discharge and during follow-ups. mMRC includes 5 grades (0, 1, 2, 3 and 4), where higher grade reflects worse health-related quality of life and higher symptom burden. |
| Direct total cost of chronic obstructive pulmonary disease management | At day of discharge (an expected median of 10 days), 30 days, 1 year after day of discharge | Direct total cost of chronic obstructive pulmonary disease management during hospitalization and follow-ups. |
| Post-bronchodilator forced expiratory volume in one second to forced vital capacity | 30 days, 1 year after day of discharge | Post-bronchodilator forced expiratory volume in one second to forced vital capacity during follow-ups |
| All-cause mortality | 30 days and 1 year after day of discharge | All-cause mortality during follow-ups |
Contacts
Primary ContactTing Yang, Doctor
Backup ContactChen Wang, Doctor
Outcome results
None listed