Quality Control for Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

Official title:

Establishment of Quality Control Index System and Strategy for Chronic Obstructive Pulmonary Disease in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604146
• Other study ID #: C2017050
• Status: Completed
• Start date: March 20, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2021
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: December 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Medical quality control intervention strategy
Training and education for diagnosis, treatment and management of COPD for doctors and nurses; Regular inspection and supervision of medical quality

Locations

Country	Name	City	State
China	Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of exacerbations of COPD (AECOPD)	The rate of exacerbations within 1 year in the intervention group and the control group will be tracked.	1 year
Secondary	rate of readmission for AECOPD	The rate of readmission for AECOPD within 1 year in the intervention group and the control group will be tracked.	1 year
Secondary	change of Forced expiratory volume in one second(FEV1)	The difference in FEV1 after bronchodilator between baseline and 1 year later	1 year