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Quality Control for Chronic Obstructive Pulmonary Disease

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03604146
Enrollment
1600
Registered
2018-07-27
Start date
2018-03-20
Completion date
2020-12-30
Last updated
2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

COPD, Quality Control

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.

Interventions

BEHAVIORALMedical 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

Sponsors

Guangzhou Institute of Respiratory Disease
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
rate of exacerbations of COPD (AECOPD)1 yearThe rate of exacerbations within 1 year in the intervention group and the control group will be tracked.

Secondary

MeasureTime frameDescription
rate of readmission for AECOPD1 yearThe rate of readmission for AECOPD within 1 year in the intervention group and the control group will be tracked.
change of Forced expiratory volume in one second(FEV1)1 yearThe difference in FEV1 after bronchodilator between baseline and 1 year later

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026