Quality Control and Evaluation in Standard COPD Management

COPD Clinical Trial

Official title:

Quality Control and Evaluation in Standard COPD Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03314077
• Other study ID #: TongjiHospitalResp.
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• GOLD 2017
Standard COPD management according to GOLD 2017, and control the quality of management in one-year follow-up.

Locations

Country	Name	City	State
China	TongjiChibi hospital	Chibi	Hubei
China	Tongji hospital	Wuhan	Hubei

Sponsors (21)

Lead Sponsor

Collaborator

Tongji Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in spirometry	Spirometry will be assessed at baseline and through study completion	1 years
Secondary	Morbidity of acute exacerbation in 1 years	Morbidity of acute exacerbation completion will be assessed at baseline and through study	1 year