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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04459143
Other study ID # CHRD 0918
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 16, 2019
Est. completion date October 31, 2020

Study information

Verified date February 2021
Source Centre Hospitalier René Dubos
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 525
Est. completion date October 31, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Advance directives
A workshop will take place during the third week of patient 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 at the end of their hospital stay, to collect their advance directives and their degree of satisfaction about this process.

Locations

Country Name City State
France Les Cèdres SSR Pneumologie / Réhabilitation Respiratoire Aincourt

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier René Dubos

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patient who write their advance directives 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 Measure of patient's satisfaction 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
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