跳至主要内容
临床试验/NCT01544543
NCT01544543已完成不适用

Validation of HealthCare Standards in COPD

Sociedad Española de Neumología y Cirugía Torácica1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
600
试验地点
1
主要终点
COPD exacerbation

研究概览

简要总结

VESALIO is a pilot study aimed at evaluating the feasibility and reliability (time stability and interobserver reliability) of healthcare quality standards in chronic obstructive pulmonary disease (COPD) recently outlined by SEPAR (Spanish Pneumology and Thoracic Surgery Society), and at establishing the foundation for a future validation (construct and criterion validation) of the aforementioned standards.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Men and women 40 years of age or older
  • Diagnosis of COPD at hospital discharge
  • Hospitalization for a COPD exacerbation

排除标准

  • Patients hospitalized for the first time at the participating site without a documented history of COPD
  • Patients currently participating of having ever participated in a COPD-related clinical trial
  • Patients with a serious disease that might affect the measured outcomes (terminal oncologic disease, neoplastic disease for which the patient is receiving chemo/radiotherapy, terminal renal insufficiency, AIDS)

结局指标

主要结局

COPD exacerbation

时间窗: Within 12 months after hospitalization

Mortality

时间窗: within 90 and 180 days after hospitalization

Healthcare-associated cost

时间窗: within 12 months after hospitalization

Hospital-stay lenght ER visits

次要结局

未报告次要终点

研究者

发起方
Sociedad Española de Neumología y Cirugía Torácica
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan José Soler Cataluna

MD, PhD

Sociedad Española de Neumología y Cirugía Torácica

研究点 (1)

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