Quality Control for Chronic Obstructive Pulmonary Disease

NCT ID: NCT03604146

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-20
• Study Completion Date: 2020-12-30

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.

Conditions

COPD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

control group

Doctors and nurses were trained to treat chronic obstructive pulmonary disease according to the GOLD guidelines.Hospital patient cohort and outpatient cohort will be setted. Subjects were interviewed and received pulmonary function tests.

No interventions assigned to this group

Intervention group

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.

Medical quality control intervention strategy

Intervention Type: BEHAVIORAL

Training and education for diagnosis, treatment and management of COPD for doctors and nurses; Regular inspection and supervision of medical quality

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role: lead

Responsible Party

Fengyan Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rongchang Chen, MD

Role: STUDY_DIRECTOR

Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University,China

Locations

Guangzhou Institute of Respiratory Health,The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

C2017050

Identifier Type: -

Identifier Source: org_study_id