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Validation of HealthCare Standards in Chronic Obstructive Pulmonary Disease (VESALIO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01544543
First Posted: March 6, 2012
Last Update Posted: March 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Juan José Soler Cataluna, Sociedad Española de Neumología y Cirugía Torácica
  Purpose
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.

Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Validation of HealthCare Standards in COPD

Resource links provided by NLM:


Further study details as provided by Juan José Soler Cataluna, Sociedad Española de Neumología y Cirugía Torácica:

Primary Outcome Measures:
  • COPD exacerbation [ Time Frame: Within 12 months after hospitalization ]
  • Mortality [ Time Frame: within 90 and 180 days after hospitalization ]
  • Healthcare-associated cost [ Time Frame: within 12 months after hospitalization ]
    Hospital-stay lenght ER visits


Enrollment: 600
Study Start Date: February 2010
Groups/Cohorts
COPD Exacerbation Cohort
Patients hospitalized for a COPD exacerbation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD patients hospitalized for an exacerbation of COPD
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544543


Locations
Spain
Hospital General de Requena
Requena, Valencia, Spain, 46340
Sponsors and Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Investigators
Principal Investigator: Juan J Soler Cataluna, MD, PhD Hospital de Requena, Valencia
  More Information

Responsible Party: Juan José Soler Cataluna, MD, PhD, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier: NCT01544543     History of Changes
Other Study ID Numbers: VES0109
First Submitted: February 21, 2012
First Posted: March 6, 2012
Last Update Posted: March 6, 2012
Last Verified: February 2012

Keywords provided by Juan José Soler Cataluna, Sociedad Española de Neumología y Cirugía Torácica:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases