Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study (AECOPD-IRS)

The purpose of this study is to investigate the demographic characteristics, clinical features, diagnoses and treatments of AECOPD hospitalized patients in China, and disease prognosis and its economic burden.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease

• Study Type: Observational
• Enrollment (Anticipated): 7600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

AECOPD-IRS plans to enroll 7600 hospitalized patients (≥ 18 years old with main diagnosis as AECOPD). Sample size estimation is based on estimated mortality of AECOPD hospitalized patients (~5%). Study patients will be recruited from 40-60 hospitals across China,each hospital will recruit 152-190 patients. Hospital selection follows a multi-stage sampling strategy.

Description

Inclusion Criteria:

≥18 years of age; hospitalized patients with main diagnosis as AECOPD.

Exclusion Criteria:

Patients diagnosed as active pulmonary tuberculosis, or acute left heart failure; Patients participating in clinical trials or intervention studies of drugs.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	All-cause and cause-specific mortality will be described.	12 months
Readmission	Readmission rate caused by AECOPD within 1 month after discharged from hospital.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause and cause-specific mortality	All-cause and cause-specific mortality will be described at different time points (1, 2, 3 years)	3 years
Recurrence of acute exacerbation of COPD	Frequency of AECOPD recurrence will be described during follow-ups, the date of first recurrence after discharge will be analysed.	3 years
Lung function and quality of life assessment	Lung function will be measured regularly, quality of life will be assessed by questionnaires	3 years
Healthcare costs	Direct costs of hospital stay will be recorded.	12 months

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: Peking University; China Soong Ching Ling Foundation

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: January 14, 2016
• First Submitted That Met QC Criteria: January 15, 2016
• First Posted (Estimate): January 18, 2016

Study Record Updates

• Last Update Posted (Estimate): February 4, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2015-88

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED