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OpenTrials
Completed

NCT Number: NCT03604146

Quality Control for Chronic Obstructive Pulmonary Disease

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Guangzhou, Guangdong, 510120, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical quality control intervention strategy

Behavioral

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

Primary outcomes

  1. rate of exacerbations of COPD (AECOPD)

    Time frame: 1 year

    The rate of exacerbations within 1 year in the intervention group and the control group will be tracked.

Secondary outcomes

  1. rate of readmission for AECOPD

    Time frame: 1 year

    The rate of readmission for AECOPD within 1 year in the intervention group and the control group will be tracked.

  2. change of Forced expiratory volume in one second(FEV1)

    Time frame: 1 year

    The difference in FEV1 after bronchodilator between baseline and 1 year later

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2018
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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