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

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ClinicalTrials.gov Identifier: NCT02657525
Recruitment Status : Active, not recruiting
First Posted : January 18, 2016
Last Update Posted : February 4, 2016
Sponsor:
Collaborators:
Peking University
China Soong Ching Ling Foundation
Information provided by (Responsible Party):
Chen Wang, China-Japan Friendship Hospital

Brief Summary:
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.

Condition or disease
Chronic Obstructive Pulmonary Disease

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 7600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study
Study Start Date : January 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases




Primary Outcome Measures :
  1. In-hospital mortality [ Time Frame: 12 months ]
    All-cause and cause-specific mortality will be described.

  2. Readmission [ Time Frame: 12 months ]
    Readmission rate caused by AECOPD within 1 month after discharged from hospital.


Secondary Outcome Measures :
  1. All-cause and cause-specific mortality [ Time Frame: 3 years ]
    All-cause and cause-specific mortality will be described at different time points (1, 2, 3 years)

  2. Recurrence of acute exacerbation of COPD [ Time Frame: 3 years ]
    Frequency of AECOPD recurrence will be described during follow-ups, the date of first recurrence after discharge will be analysed.

  3. Lung function and quality of life assessment [ Time Frame: 3 years ]
    Lung function will be measured regularly, quality of life will be assessed by questionnaires

  4. Healthcare costs [ Time Frame: 12 months ]
    Direct costs of hospital stay will be recorded.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.


Additional Information:

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Responsible Party: Chen Wang, Prof.Dr., China-Japan Friendship Hospital
ClinicalTrials.gov Identifier: NCT02657525     History of Changes
Other Study ID Numbers: 2015-88
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases