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Completed

NCT Number: NCT01544543

Validation of HealthCare Standards in Chronic Obstructive Pulmonary Disease

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General de Requena

Requena, Valencia, 46340, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. COPD exacerbation

    Time frame: Within 12 months after hospitalization

  2. Mortality

    Time frame: within 90 and 180 days after hospitalization

  3. Healthcare-associated cost

    Time frame: within 12 months after hospitalization

    Hospital-stay lenght ER visits

Sponsors and collaborators

Lead sponsor

Sociedad Española de Neumología y Cirugía Torácica

Other

Registry information

Official study title

Validation of HealthCare Standards in COPD

Acronym: VESALIO

Important dates

Study start
2010
First posted
Mar 6, 2012
Registry last updated
Mar 6, 2012

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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