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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Juan José Soler Cataluna, Sociedad Española de Neumología y Cirugía Torácica
ClinicalTrials.gov Identifier:
NCT01544543
First received: February 21, 2012
Last updated: March 5, 2012
Last verified: February 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Sociedad Española de Neumología y Cirugía Torácica:

Primary Outcome Measures:
  • COPD exacerbation [ Time Frame: Within 12 months after hospitalization ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: within 90 and 180 days after hospitalization ] [ Designated as safety issue: No ]
  • Healthcare-associated cost [ Time Frame: within 12 months after hospitalization ] [ Designated as safety issue: No ]
    Hospital-stay lenght ER visits


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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 21, 2012
Last Updated: March 5, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Sociedad Española de Neumología y Cirugía Torácica:
COPD

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

ClinicalTrials.gov processed this record on May 16, 2013