Clinical trial NCT03604146: Quality Control for Chronic Obstructive Pulmonary Disease
Official title: Establishment of Quality Control Index System and Strategy for Chronic Obstructive Pulmonary Disease in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: COPD
Quality Control
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 1600
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Grade II - III hospital in Guangdong Province

Brief summary: This is a 1 year longitudinal study to establish a related index system for chronic obstructive pulmonary disease(COPD) quality control.Clinical and economic data of COPD patients will be collected and analyzed.

Detailed description: Sixteen hospitals in Guangdong Province were randomly divided into control group and intervention group.Doctors and nurses of intervention group were trained treat chronic obstructive pulmonary disease according to the GOLD(Global InitiaTive of Chronic Obstructive Lung Disease) guidelines，while those in the control group will not receive any training from research team. Hospital patient cohort and outpatient cohort will be setted. Subjects were interviewed and received pulmonary function tests.All patients will be followed and events of acute exacerbation will be recorded.Factors that influence patient prognosis and economic-health benefits will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Patients was diagnosed as COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines older than 40 years old.Patients was hospitalized for AECOPD or visiting outpatient department for COPD.

  * A signed and dated written informed consent is obtained prior to participation.
  * Able to comply with the requirements of the protocol and be available for study visits over 1 years.

Exclusion Criteria:

A COPD subject will not be eligible for inclusion in this study if any of the following criteria apply:

* Known respiratory disorders, or disorders identified at screening/visit

  1 (including identification on the first CT scan), other than COPD (e.g.: lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis)
* Having undergone lung surgery (e.g. lung reduction, lung transplant)
* Severe liver and kidney dysfunction
* Have cancer or have had cancer in the 5 years prior to study entry
* Taking part in a blinded drug study

Primary outcomes:
measure: rate of exacerbations of COPD (AECOPD)
timeFrame: 1 year
Secondary outcomes:
measure: rate of readmission for AECOPD
timeFrame: 1 year
measure: change of Forced expiratory volume in one second(FEV1)
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University,China
name: Rongchang Chen, MD
role: STUDY_DIRECTOR
References: