Validation of HealthCare Standards in Chronic Obstructive Pulmonary Disease

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT01544543
• Lead Sponsor: Sociedad Española de Neumología y Cirugía Torácica

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Status Verified: 2012-02
• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-03-05
• Last Update Submitted: 2012-03-05
• Study First Posted: 2012-03-06
• Last Update Posted: 2012-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Healthcare-associated cost	within 12 months after hospitalization	Hospital-stay lenght ER visits
COPD exacerbation	Within 12 months after hospitalization
Mortality	within 90 and 180 days after hospitalization

Trial Locations

Locations (1)

Hospital General de Requena; 🇪🇸 Requena, Valencia, Spain