Quality Control for Chronic Obstructive Pulmonary Disease

NCT03604146 | Completed

• 1 other identifier: C2017050
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

COPD; Quality Control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• rate of readmission for AECOPD

  1 year

• change of Forced expiratory volume in one second(FEV1)

  1 year

Study Arms (2)

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.

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.

Behavioral: Medical quality control intervention strategy

Interventions

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

Intervention group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Grade II - III hospital in Guangdong Province

You may qualify if:

• 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.

You may not qualify if:

• Known respiratory disorders, or disorders identified at screening/visit
• (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

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rongchang Chen, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 27, 2018
• Study Start: March 20, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 30, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

CN (1)