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NCT Number: NCT03314077

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

TongjiChibi hospital, Chibi, Hubei, China

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

GOLD 2017

Other

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

Primary outcomes

  1. Change in spirometry

    Time frame: 1 years

    Spirometry will be assessed at baseline and through study completion

Secondary outcomes

  1. Morbidity of acute exacerbation in 1 years

    Time frame: 1 year

    Morbidity of acute exacerbation completion will be assessed at baseline and through study

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

  • Central health center in Yongjiahe Town,China
  • Chinses PLA general hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • First Hospital of China Medical University
  • Guilin Medical University, China
  • 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
  • Second Xiangya Hospital of Central South University
  • 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 of Zhejiang University School of Medicine
  • 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

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2017
Registry last updated
Mar 25, 2020

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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