NCT05682404

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a public health problem responsible for high mortality rate and significant costs for society. The disease evolution is punctuated by exacerbations worsening the health state of patients. Many guidelines of care procedures have been written but many disparities persist in medical practices. This pilot prospective observational study is an overview of current local practices in the university health center of Grenoble Alpes and it is the first step towards developing a regional observatory in order to standardize and improve patient cares. The primary outcome is to compare the international guidelines to the local practices regarding the prescription of key treatments of exacerbation, especially antibiotics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2019

Completed
3.7 years until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

April 16, 2019

Last Update Submit

January 10, 2023

Conditions

Keywords

COPDexacerbationProspectiveObservationalProfessional practices guidelines

Outcome Measures

Primary Outcomes (1)

  • Percentage of antibiotics prescriptions following the guidelines in COPD exacerbation.

    Adherence to guidelines regarding antibiotics prescription in COPD exacerbation that is justified by : * sputum purulence * severe symptoms * severe comorbidities * pneumonia

    up to 30 days

Secondary Outcomes (7)

  • Percentage of corticosteroids prescriptions following the guidelines in COPD exacerbation.

    up to 30 days

  • Percentage of hospitalization of patients following the guidelines in COPD exacerbation.

    up to 30 days

  • Percentage of non invasive ventilation following the guidelines in COPD exacerbation.

    up to 30 days

  • Percentage of invasive ventilation following the guidelines in COPD

    up to 30 days

  • Percentage of minimal medical examinations following the guidelines in COPD exacerbation.

    up to 30 days

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Every Patient who is admitted for COPD exacerbation in emergency department or pneumology department or intensive care unit of university health center of Grenoble Alpes during the period of data collection.

You may qualify if:

  • Patient older than 18 years (included)
  • Known or suspected Chronic Obstructive Pulmonary Disease
  • Admitted for COPD exacerbation in emergency department or pneumology department or intensive care unit of university health center of Grenoble Alpes during the period of data collection.

You may not qualify if:

  • opposition to participate at the study
  • Patients under the law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble Alpes

Grenoble, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2019

First Posted

January 12, 2023

Study Start

October 1, 2017

Primary Completion

March 30, 2018

Study Completion

June 30, 2018

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations