Chronic Obstructive Pulmonary Disease (COPD) and Advance Directives (DIABPCO)

February 1, 2021 updated by: Centre Hospitalier René Dubos
The aim of this study is to evaluate if the participation of COPD patients to a workshop on advance directives increases the number of patients who write them.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Chronic Obstructive Disease is a common disease and should be the third leading cause of death in 2020. Patient hospitalized for an exacerbation of their COPD have a median survival of 2 years and 50% risk of being rehospitalized within 6 months.

COPD patients may have symptoms that impair their life quality significantly and sometimes more than patients with cancer. This is particularly the case for dyspnea, which is frequently present.

In the study, Investigators propose the setting up of health workshop on advance directives. This workshop is for sever or very severe COPD patients during their hospital stay in the post-acute care and pulmonary rehabilitation service.

In this unit, investigators welcome patient from all the region of Ile de France for a hospital stay of approximately 6 weeks. A first workshop will take place during the third week of their care to inform them about COPD, exacerbations, prognostic and advance directives. Then, a personal interview with patients who have participated to this workshop will take place to collect their advance directives and their degree of satisfaction about this process.

Study Type

Observational

Enrollment (Actual)

525

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

      • Aincourt, France, 95510
        • Les Cèdres SSR Pneumologie / Réhabilitation Respiratoire

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with COPD Gold 3 or 4 who accept to participate to the workshop

Description

Inclusion Criteria:

  • COPD Gold 3 or 4 and Curtis criteria

Exclusion Criteria:

  • left to the discretion of the investigator if he finds that it will not be beneficial for the patient : for example if the workshop is judged to be at risk of being anxiety-provoking

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patient who write their advance directives
Time Frame: At the end of patient hospital stay, approximately 6 weeks
The Primary Outcome Measure is the collect of the number of patients who write their advance directives after their participation of the health workshop
At the end of patient hospital stay, approximately 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of patient's satisfaction
Time Frame: At the end of patient hospital stay, approximately 6 weeks
The satisfaction of patient was measured with a satisfaction questionnaire scale based on their feelings about the workshop. For each item, patient ticks : Strongly agree, Agree, Neither agree or disagree, Disagree or Strongly disagree
At the end of patient hospital stay, approximately 6 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Jean-François Boitiaux, Centre Hospitalier René Dubos

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 (Actual)

May 16, 2019

Primary Completion (Actual)

October 31, 2020

Study Completion (Actual)

October 31, 2020

Study Registration Dates

First Submitted

July 1, 2020

First Submitted That Met QC Criteria

July 1, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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