Validation of HealthCare Standards in Chronic Obstructive... | NCT01544543

Studies
Validation of HealthCare Standards in Chronic Obstructive Pulmonary Disease

NCT01544543

Sponsor

Sociedad Española de Neumología y Cirugía Torácica

Status

Completed

Last Update Posted

Mar 6, 2012Estimated

Enrollment

600Actual

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 21, 2012

First Submission Date that Met QC Criteria

Mar 5, 2012

First Posted Date

Mar 6, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2012

Last Update Posted Date

Mar 6, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Juan José Soler Cataluna, MD, PhD, Sociedad Española de Neumología y Cirugía TorácicaPrincipal Investigator

Lead Sponsor

Sociedad Española de Neumología y Cirugía TorácicaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Actual

Label	Type	Description	Intervention Names
COPD Exacerbation Cohort		Patients hospitalized for a COPD exacerbation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

COPD patients hospitalized for an exacerbation of COPD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Juan J Soler Cataluna, MD, PhD	Hospital de Requena, Valencia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital General de Requena		Requena	Valencia	46340	Spain

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided