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

March 5, 2012 updated by: Juan José Soler Cataluna, Sociedad Española de Neumología y Cirugía Torácica

Validation of HealthCare Standards in COPD

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.

Study Overview

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Spain
- Valencia
  - Requena, Valencia, Spain, 46340
    - Hospital General de Requena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COPD patients hospitalized for an exacerbation of COPD

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
COPD Exacerbation Cohort Patients hospitalized for a COPD exacerbation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD exacerbation Time Frame: Within 12 months after hospitalization		Within 12 months after hospitalization
Mortality Time Frame: within 90 and 180 days after hospitalization		within 90 and 180 days after hospitalization
Healthcare-associated cost Time Frame: within 12 months after hospitalization	Hospital-stay lenght ER visits	within 12 months after hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sociedad Española de Neumología y Cirugía Torácica

Investigators

Principal Investigator: Juan J Soler Cataluna, MD, PhD, Hospital de Requena, Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

March 5, 2012

First Posted (Estimate)

March 6, 2012

Study Record Updates

Last Update Posted (Estimate)