Chronic Obstructive Pulmonary DiseaseDIABPCONCT04459143
Chronic Obstructive Pulmonary Disease (COPD) and Advance Directives
An observational study of Chronic Obstructive Pulmonary Disease, run by Hôpital NOVO at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Advance directives
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 525 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2019to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with COPD Gold 3 or 4 who accept to participate to the workshop
Who may be able to join
- COPD Gold 3 or 4 and Curtis criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Les Cèdres SSR Pneumologie / Réhabilitation Respiratoire
Aincourt, 95510
About this study
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Advance directives
- Keywords
- COPD, Palliative care, Advance directives, Exacerbation, Dyspnea
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance directivesBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the end of patient hospital stay, approximately 6 weeks
Secondary outcomes (1)
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
Measured: At the end of patient hospital stay, approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start16 May 2019
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François Boitiaux, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459143
- Sponsor's protocol ID
- CHRD 0918
- Acronym
- DIABPCO
- Status last verified
- Feb 2021
- First submitted
- 1 Jul 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Obstructive Pulmonary Disease (COPD) and Advance Directives
- ClinicalTrials.gov ID
- NCT04459143
- Acronym / sponsor ID
- DIABPCO / CHRD 0918
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Palliative care, Advance directives, Exacerbation, Dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 525 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 16 May 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with COPD Gold 3 or 4 who accept to participate to the workshop
Key inclusion criteria (1 listed)
- COPD Gold 3 or 4 and Curtis criteria
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advance directivesA 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. | Behavioural | – |
Primary outcome
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
1 secondary outcome
Measure of patient's satisfaction
Time frame: At the end of patient hospital stay, approximately 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François Boitiaux principal investigator
Hôpital NOVO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Hôpital NOVO at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient who write their advance directives (time frame: At the end of patient hospital stay, approximately 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.