Severe COPDAIRNCT03915743
Advance Care Planning Individualised Approach and Research Projec
A study testing palliative care in people with Severe COPD, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
The study will investigate the effect of a palliative approach in the out-patient management of patients with COPD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe COPD
- What is being tested?
- palliative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2019to 1 Nov 2020
- 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
- • Diagnosis of COPD by spirometry
- Patients followed in Herlev and Gentofte hospitals' respiratory out-patient-clinics or admitted to Herlev or Gentofte hospital for acute exacerbation
- 2 or more admissions for acute exacerbation of COPD within the last 12 months
- CAT > 20
- Cognitive and linguistic able to understand and give informed consent
Who cannot join
- • Expected remaining life time less than 6 months due to other disease than COPD e.g. active cancer
- Participating in other studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The AIR Project - Advance Care Planning Individualised Approach and Research Project. A Single Center Randomized Controlled Trial
The study will investigate the effect of a palliative approach in the out-patient management of patients with COPD.
Read the detailed description
Randomised control trial. A total of 90 patients will be randomise 1:1 to either palliative intervention or standard care.
The intervention group will receive follow up in a newly established outpatient clinic for COPD in the specialized palliative united and the control group will receive standard follow up in the respiratory out-patient clinic.
- Conditions
- Severe COPD
- Being tested
- palliative care
- Keywords
- Palliative care, Out-patient clinic, COPD symptom burden
- 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.
palliative careOther
complex and multi-faceted individualized palliative care
| Study group | Role | What they receive |
|---|---|---|
| Palliative care | Experimental | Specialized palliative care arm in a newly formed COPD outpatient clinic Receives: Other: palliative care |
| Usual care | No intervention | Usual care in a standard pulmonary out-patient clinic. Treatment as described in national standards. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in total Hospital and Anxiety Depression scale (HADS) at 6 months
questionnaire measuring anxiety and Depression in 2 subscales in this study we use the total value of the 2 subscales combined. The higher the number the worse the psychological impact. HADS total was a range from 0 to 24 where 0 is no psychological distress
Measured: baseline, 3 and 6 months
Secondary outcomes (3)
Change from Baseline EORTC QLQ-C15-PAL at 6 months
questionnaire, consists of 14 questions and a license audit goal from 1 to 7 where 7 is the best possible quality of life.For the first 14 questions about symptoms, the scale goes from 1 to 4 where 4 is the worst
Measured: baseline, 3 and 6 months
Change from Baseline Life-Space Assessment (LSA) at 6 months
questionnaire,5 questions about where the patient has been in the last 4 weeks. Question 1 is other than bedroom and question 5 is out of his home town. In addition, questions are asked about how frequently and on the use of aids.finally the scales are converted to numerical value between 0 and 120 where 0 is worst and expresses that the patient is constant in bed
Measured: baseline, 3 and 6 months
Change from Baseline copd assessment test (CAT) at 6 months
questionnaire. 8 items questionnaire where there should be between 0 and 5 where 5 is the worst. Together, this gives a total scale between 0 and 40 where 40 is worst
Measured: baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 May 2019
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe COPDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Kristoffer Marsaa, Herlev and Gentofte Hospital
- Investigators
- Jens-Ulrik Jensen, Phd MD, Study director, pulmonary department Herlev and Gentofte HospitalTorgny Wilcke Wilcke, phd MD, Study director, pulmonary department Herlev and Gentofte HospitalJanni Mendahl, APN, Study director, Palliative unite Herlev and Gentofte HospitalCharlotte Ulrik, Prof. MD DMSc, Study director, Pulmonary department Hvidovre HospitalNina Godtfredsen, phd MD, Study chair, Pulmonary department Hvidovre HospitalKristoffer Marså, MD, Principal investigator, Palliative Unite Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915743
- Sponsor's protocol ID
- AIR
- Acronym
- AIR
- Status last verified
- Feb 2021
- First submitted
- 27 Jan 2019
- Last updated
- 12 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The AIR Project - Advance Care Planning Individualised Approach and Research Project. A Single Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03915743
- Acronym / sponsor ID
- AIR / AIR
- Conditions
- Severe COPD
- Keywords
- Palliative care, Out-patient clinic, COPD symptom burden
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 16 Apr 2019 (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 study will investigate the effect of a palliative approach in the out-patient management of patients with COPD.
Detailed description
Randomised control trial. A total of 90 patients will be randomise 1:1 to either palliative intervention or standard care.
The intervention group will receive follow up in a newly established outpatient clinic for COPD in the specialized palliative united and the control group will receive standard follow up in the respiratory out-patient clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Palliative care | Experimental | Other: palliative careSpecialized palliative care arm in a newly formed COPD outpatient clinic |
| Usual care | No intervention | –Usual care in a standard pulmonary out-patient clinic. Treatment as described in national standards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Diagnosis of COPD by spirometry
Key exclusion criteria (2 listed)
- • Expected remaining life time less than 6 months due to other disease than COPD e.g. active cancer
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 |
|---|---|---|
| palliative carecomplex and multi-faceted individualized palliative care | Other | Palliative care |
Primary outcome
Change from Baseline in total Hospital and Anxiety Depression scale (HADS) at 6 months
Time frame: baseline, 3 and 6 months
questionnaire measuring anxiety and Depression in 2 subscales in this study we use the total value of the 2 subscales combined. The higher the number the worse the psychological impact. HADS total was a range from 0 to 24 where 0 is no psychological distress
3 secondary outcomes
Change from Baseline EORTC QLQ-C15-PAL at 6 months
Time frame: baseline, 3 and 6 months
Change from Baseline Life-Space Assessment (LSA) at 6 months
Time frame: baseline, 3 and 6 months
Change from Baseline copd assessment test (CAT) at 6 months
Time frame: baseline, 3 and 6 months
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Jens-Ulrik Jensen, Phd MD study director
pulmonary department Herlev and Gentofte Hospital
Torgny Wilcke Wilcke, phd MD study director
pulmonary department Herlev and Gentofte Hospital
Janni Mendahl, APN study director
Palliative unite Herlev and Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing palliative care in people with Severe COPD, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 12 Feb 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 Denmark. 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 was stopped early (reason given: COVID-19). Results are not available in the source record.
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?
Change from Baseline in total Hospital and Anxiety Depression scale (HADS) at 6 months (time frame: baseline, 3 and 6 months). 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 12 Feb 2021.