COPDNCT02223780
Early Palliative Care for Patients With Severe and Very Severe COPD: a Randomised Study
A study testing early palliative care in people with COPD, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a common and, despite existing treatment options, progressive lung disease. Patients with COPD often have only limited access to palliative care. The goal of this research project is to improve the quality of life of patients with COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- early palliative care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2013to Jul 2017
- Phase
- Interventional
- 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
Who may be able to join
- COPD defined according to GOLD criteria (FEV1/FVC < 70%) stage III or IV (FEV1 < 50% predicted)
- and/or long term treatment with either domiciliary oxygen or home mechanical ventilation
- and or one or more hospital admissions in the previous year for an acute exacerbation
Who cannot join
- Moderate or severe cognitive impairment (MMSE<20)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Early Introduction of Specialized Palliative Care Limit Intensive Care, Emergency and Hospital Admissions in Patients With Severe and Very Severe COPD? A Randomized Study
Chronic obstructive pulmonary disease (COPD) is a common and, despite existing treatment options, progressive lung disease. Patients with COPD often have only limited access to palliative care. The goal of this research project is to improve the quality of life of patients with COPD.
Background In many cases, the symptoms of advanced COPD (including shortness of breath, pain and depression) are insufficiently alleviated. In addition, often in connection with an infection, patients frequently suffer from respiratory decompensation; this may lead to invasive interventions as well as the admission to the emergency room or an intensive care unit. It may ultimately lead to the death of the patient.
Read more
Aim This study aims to show that early palliative care can reduce the number of necessary invasive interventions and improve the quality of life of patients with COPD. For this purpose, a group of patients receiving early, standardized palliative care will be compared to a group of patients receiving customary treatment only, without systematic intervention by palliative care experts.
Significance The results of this study should make it possible to efficiently use the medical resources which are required for the appropriate care of patients with COPD. The goal is the best possible quality of life and better coordination of the measures taken, especially with regard to the area of acute care and the wishes of the patient.
Read the detailed description
The primary objective of the study is to assess the effectiveness of the introduction of early specialized palliative care on hospital, intensive care unit and emergency admissions of patients with severe and very severe COPD
Secondary objectives are:
The impact of early palliative care on the mood and anxiety of patients with severe and very severe COPD The impact of early palliative care on the health-related quality of life of patients with severe and very severe COPD.
The impact of early palliative care on the prescription of antibiotics during the last month of life of patients 4. The impact of early palliative care on advance care planning and end-of-life decision-making will be compared between the two groups Methodology Randomized study to one of the two groups in a ratio without stratification.
Study Duration 3 years Study Center(s) Single-center study Number of Subjects 180 patients Intervention Early specialized palliative care intervention Significance Given the trends toward aggressive and costly care near end-of-life among patients with COPD, a timely introduction of palliative care may limit unnecessary and burdensome personal and societal costs, and invasive approaches. The results of this study may provide some direction for future palliative care interventions in this particular population
- Conditions
- COPD
- Being tested
- early palliative care
- Keywords
- COPD, palliative care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early palliative careOther
the patients will benefit from an early palliative care consultation
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | standard management Receives: Other: early palliative care |
| early palliative care | Active comparator | early palliative care Receives: Other: early palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay hospital, intensive care unit and emergency admissions
number of days
Measured: 1 year
Secondary outcomes (2)
depression and anxiety
HADS
Measured: 1 year
Health related quality of life assessed by a generic questionnaire
SF-36
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startSep 2013
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Principal investigator, Jean-Paul Janssens, University Hospital, Geneva
- Investigators
- Jean-Paul Janssens, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223780
- Sponsor's protocol ID
- Projet 13-102
- Other IDs
- 406740_145086/1
- Status last verified
- Oct 2021
- First submitted
- 8 Aug 2014
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weber C, Stirnemann J, Herrmann FR, Pautex S, Janssens JP. Can early introduction of specialized palliative care limit intensive care, emergency and hospital admissions in patients with severe and very severe COPD? a randomized study. BMC Palliat Care. 2014 Oct 21;13:47. doi: 10.1186/1472-684X-13-47.
PubMed 25927907
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Early Introduction of Specialized Palliative Care Limit Intensive Care, Emergency and Hospital Admissions in Patients With Severe and Very Severe COPD? A Randomized Study
- ClinicalTrials.gov ID
- NCT02223780
- Acronym / sponsor ID
- Projet 13-102
- Conditions
- COPD
- Keywords
- COPD, palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Sep 2013 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 22 Aug 2014 (estimated)
- 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.
Chronic obstructive pulmonary disease (COPD) is a common and, despite existing treatment options, progressive lung disease. Patients with COPD often have only limited access to palliative care. The goal of this research project is to improve the quality of life of patients with COPD.
Background In many cases, the symptoms of advanced COPD (including shortness of breath, pain and depression) are insufficiently alleviated. In addition, often in connection with an infection, patients frequently suffer from respiratory decompensation; this may lead to invasive interventions as well as the admission to the emergency room or an intensive care unit. It may ultimately lead to the death of the patient.
Aim This study aims to show that early palliative care can reduce the number of necessary invasive interventions and improve the quality of life of patients with COPD. For this purpose, a group of patients receiving early, standardized palliative care will be compared to a group of patients receiving customary treatment only, without systematic intervention by palliative care experts.
Significance The results of this study should make it possible to efficiently use the medical resources which are required for the appropriate care of patients with COPD. The goal is the best possible quality of life and better coordination of the measures taken, especially with regard to the area of acute care and the wishes of the patient.
Detailed description
The primary objective of the study is to assess the effectiveness of the introduction of early specialized palliative care on hospital, intensive care unit and emergency admissions of patients with severe and very severe COPD
Secondary objectives are:
The impact of early palliative care on the mood and anxiety of patients with severe and very severe COPD The impact of early palliative care on the health-related quality of life of patients with severe and very severe COPD.
The impact of early palliative care on the prescription of antibiotics during the last month of life of patients 4. The impact of early palliative care on advance care planning and end-of-life decision-making will be compared between the two groups Methodology Randomized study to one of the two groups in a ratio without stratification.
Study Duration 3 years Study Center(s) Single-center study Number of Subjects 180 patients Intervention Early specialized palliative care intervention Significance Given the trends toward aggressive and costly care near end-of-life among patients with COPD, a timely introduction of palliative care may limit unnecessary and burdensome personal and societal costs, and invasive approaches. The results of this study may provide some direction for future palliative care interventions in this particular population
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Other: early palliative carestandard management |
| early palliative care | Active comparator | Other: early palliative careearly palliative care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD defined according to GOLD criteria (FEV1/FVC < 70%) stage III or IV (FEV1 < 50% predicted)
Key exclusion criteria (1 listed)
- Moderate or severe cognitive impairment (MMSE<20)
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 |
|---|---|---|
| early palliative carethe patients will benefit from an early palliative care consultation | Other | control, early palliative care |
Primary outcome
length of stay hospital, intensive care unit and emergency admissions
Time frame: 1 year
number of days
2 secondary outcomes
depression and anxiety
Time frame: 1 year
Health related quality of life assessed by a generic questionnaire
Time frame: 1 year
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 8 Nov 2021.
- Derived from this study: PubMed 25927907Weber C, Stirnemann J, Herrmann FR, Pautex S, Janssens JP. Can early introduction of specialized palliative care limit intensive care, emergency and hospital admissions in patients with severe and very severe COPD? a randomized study. BMC Palliat Care. 2014 Oct 21;13:47. doi: 10.1186/1472-684X-13-47.
- link of the national fundLink provided by the sponsor.
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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-Paul Janssens, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early palliative care in people with COPD, run by University Hospital, Geneva at 1 site in Switzerland.
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 3 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 8 Nov 2021. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
length of stay hospital, intensive care unit and emergency admissions (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02223780, which also lists 1 linked publication.
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 8 Nov 2021.