Quality Control for Chronic Obstructive Pulmonary Disease

Completed

• Conditions: COPD
• Interventions: Behavioral: Medical quality control intervention strategy

• Registration Number: NCT03604146
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

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.

Study Timeline

• Study Start: 2018-03-20
• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-27
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-06
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention group	Medical quality control intervention strategy	Doctors and nurses 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.

Primary Outcome Measures

Name	Time	Method
rate of exacerbations of COPD (AECOPD)	1 year	The rate of exacerbations within 1 year in the intervention group and the control group will be tracked.

Secondary Outcome Measures

Name	Time	Method
change of Forced expiratory volume in one second(FEV1)	1 year	The difference in FEV1 after bronchodilator between baseline and 1 year later
rate of readmission for AECOPD	1 year	The rate of readmission for AECOPD within 1 year in the intervention group and the control group will be tracked.

Trial Locations

Locations (1)

Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China