- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04459143
Chronic Obstructive Pulmonary Disease (COPD) and Advance Directives (DIABPCO)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Aincourt, France, 95510
- Les Cèdres SSR Pneumologie / Réhabilitation Respiratoire
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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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
Sponsor
Investigators
- Principal Investigator: Jean-François Boitiaux, Centre Hospitalier René Dubos
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRD 0918
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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