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临床试验/NCT04318912
NCT04318912尚未招募不适用

An Observational Registry Study for Management of COPD Patients in China

China-Japan Friendship Hospital0 个研究点目标入组 5,000 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
5,000
主要终点
Characterize COPD Disease Severity in Clinical Practice

研究概览

简要总结

This is a multi-center, observational registry study involving secondary and tertiary hospitals across China. The objective is to study the disease burden, disease progression, comorbidities, treatment pattern and real-world cost, effectiveness and safety of different therapy options for COPD patients in Chinese clinical practice in China.

详细描述

COPD is the most common chronic respiratory disease in China and has caused significant economic and humanistic burden. Patient reported outcomes (PRO) have been widely used to assess disease activity and quality of life for COPD patients. Wearable devices enable recording activity data of patients continuously and automatically. The objective of the study is to study the disease burden, disease progression, comorbidities, treatment pattern and real-world cost, effectiveness and safety of different therapy options for COPD patients in Chinese clinical practice in China. This is a multi-center, observational registry study involving secondary and tertiary hospitals across China. 3000-5000 participants are planned to be recruited. Each participant will be followed-up at baseline and every 3 months. Clinical assessment data, laboratory examination data and cost data are captured from electronic medical records (EMR). Patient-reported outcome (PRO) data are collected via smartphone app. Part of patients will receive wearable devices to record digital health technology (DHT) data. As the first ever observational registry focused on COPD stable-period management, this study can provide more information on these following issues. (1) Annual changes in COPD prevalence, treatment pattern and economic burden in China. (2) Assessing the real-world effectiveness and safety of different treatment patterns of COPD via EMR, PRO and DHT. (3) Cost-effectiveness and budget impact to the public healthcare funds of different treatment patterns of COPD.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults age 40 or older with a diagnosis of chronic obstructive pulmonary disease (COPD) having been prescribed any COPD treatment (initial or subsequent) outside of a clinical trial.
  • Have plans for future visits at the site for continued management of COPD.

排除标准

  • Inability to provide written informed consent/assent.
  • Being enrolled in any interventional study or trial for COPD treatment. Note: Patient may be enrolled in other registries or studies where COPD treatment outcomes are observed and/or reported (such as center-based registries).

结局指标

主要结局

Characterize COPD Disease Severity in Clinical Practice

时间窗: 2 years

Pulmonary Function Test measured by protable spirometer can represent the severity stages of COPD

Characterize COPD Disease Activity in Clinical Practice

时间窗: 2 years

Acute exacerbation of symptoms can reflect the disease activity and disease control of COPD.

次要结局

  • Evaluate Medical Expenditure in Clinical Practice(2 years)
  • Evaluate Patient Reported Outcome(2 years)
  • Evaluate Health Related Quality of Life(2 years)
  • Evaluate Digital Health Technology Outcome(2 years)

研究者

发起方
China-Japan Friendship Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hongtao Niu

Resident Doctor

China-Japan Friendship Hospital

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