Quality Control and Evaluation in Standard COPD Management

There is lack of quality control and evaluation indexes for standard COPD management in hospitals in China, leading to nonstandard in COPD management and discrepancy in therapeutic efficiency. This study focuses on establishing quality control and evaluation indexes for standard COPD management in hospitals in China, and evaluating the therapeutic efficiency after standard COPD management. This part is a prospective cohort which lasts 2 years. After standard COPD management according to GOLD 2017 by doctors in hospitals in China, patients will be followed up for their outcome after 1 year. Several indexes will be selected to evaluate the quality control of standard COPD management and its efficiency. The controls are from hospital-based subjects with a retrospective cohort study.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: GOLD 2017

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• China
  • Hubei
    • Chibi, Hubei, China
      • TongjiChibi hospital
    • Wuhan, Hubei, China
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Clinic-based population

Description

Inclusion Criteria:

• 1.Clinical manifestation of COPD; post bronchodilator FEV1/FVC<0.70

Exclusion Criteria:

• 1. lung cancer. 2. Any history of psychiatric disorders. 3.HIV positive. 4.Breastfeeding, pregnancy or planning to be pregnant. 5.Estimated lifetime less than 1 years due to underlying diseases.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard managed subjects; COPD patients accepted standard COPD management.	Other: GOLD 2017; Standard COPD management according to GOLD 2017, and control the quality of management in one-year follow-up.
Controls; COPD patients didn't accepted standard COPD management or quality control, who are from hospital subjects with a retrospective cohort study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in spirometry	Spirometry will be assessed at baseline and through study completion	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity of acute exacerbation in 1 years	Morbidity of acute exacerbation completion will be assessed at baseline and through study	1 year

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Collaborators: Shanghai Zhongshan Hospital; Peking University Third Hospital; Huashan Hospital; First Affiliated Hospital Xi'an Jiaotong University; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; First Hospital of China Medical University; Yiwu Central Hospital; Affiliated hospital of Guilin medical university,China; University hospital of Hubei university for nationalities,China; TongjiChibi hospital,China; Central health center in Yongjiahe Town,China; Chinses PLA general hospital; the second Xiangya hospital of Central sounth university; the fourth affiliated hospital, Zhejiang university school of medcine; Shanghai Xuhui Central Hospital; Sijing hospital of Songjiang District in Shanghai; Youxian People's Hospital; Tong Ren hospital Shanghai Jiao Tong university school of medicine; Zhejiang Putuo Hospital; Jing-An District Center Hospital of Shanghai (Huashan Hospital Fudan University Jing-An Branch), Shanghai Medical College, Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2017
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: October 15, 2017
• First Submitted That Met QC Criteria: October 15, 2017
• First Posted (ACTUAL): October 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: TongjiHospitalResp.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No