COPDREPORTNCT04249388
Characteristics of People With Advanced Chronic Obstructive Pulmonary Disease (COPD) - A Multicenter Study
An observational study of COPD, run by University Hospital Bispebjerg and Frederiksberg at 4 sites in Denmark.
Trial summary
Pulmonary rehabilitation (PR) is a cornerstone of care for people with COPD. There is robust evidence that PR improves exercise capacity, enhances health-related quality of life (QoL) and reduces healthcare utilization. PR is strongly recommended in guidelines for COPD management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- How many people
- 102 participants
- Where
- 4 sitesDenmark
- Study dates
- 1 Feb 2020to 31 Dec 2022
- 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
- Adult, Older adult
Study population: This is a prospective observational study of patients with COPD who declines participation in a conventional out-patient hospital-based PR program.
Who may be able to join
- Clinical diagnosis of COPD defined as a ratio of forced expiratory volume at one second (FEV1) to forced vital capacity < 0.70
- FEV1 <50%, corresponding to severe or very severe COPD
- Symptoms equivalent to the Medical Research Council (MRC) from 2 to 5
- Declines to participate in a conventional out-patient hospital-based PR program
Who cannot join
- Concurrent participation in or recent completion of pulmonary rehabilitation within the last twelve months.
- Dementia/ Cognitive impairment or uncontrolled psychiatric illness,
- An impaired hearing and / or vision which causes the instructions in the assessment is not understood.
- language difficulties which causes inability to follow instruction or complete patient reported outcome measures (PROM.)
- Any comorbidity that are contraindicated to the assesment protocol.
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Bispebjerg and Frederiksberg University Hospital
Copenhagen, Copenhagen North West, 2400
Gentofte and Herlev University Hospital
Gentofte Municipality, Hellerup, 2900
Nordsjaelland University Hospital
Hillerød, 3400
Amager and Hvidovre University Hospital
Hvidovre, Danmark, 2650
About this study
Official title: Rethink Pulmonary Rehabilitation (REPORT Study)
Pulmonary rehabilitation (PR) is a cornerstone of care for people with COPD. There is robust evidence that PR improves exercise capacity, enhances health-related quality of life (QoL) and reduces healthcare utilization. PR is strongly recommended in guidelines for COPD management. Despite the compelling evidence for its benefits, PR is delivered to less than 30% of people with COPD. Access is particularly challenging, an especially for those with the most progressed disease stages.
We recently completed a randomized clinical trial, showing that approximately 1.100 patients annually are offered conventional hospital-based PR during routine consultations in the Capital Region of Denmark, but at least 700 patients declines participation.
No major cohort studies have been published from people with severe and advanced COPD who opt out of traditional pulmonary rehabilitation. By establishing such cohort study, objective and qualitative knowledge from assessments and patient interviews is collected in patients we have very limited access to and knowledge of. Additionally, the collected data will give a deeper insight and understanding and possibly enable us to design new delivery models to be tested in proper study designs.
Read the detailed description
Objective This cohort study aims to describe and understand differences and similarities in characteristics among people with severe and advanced COPD who opt-in or opt out of PR services.
The study includes data from: socio-demographic, anthropometric, physical (function, activity, muscle strength, balance) characteristics as well as self-reported symptoms of anxiety, depression, fatigue, pain, lung symptoms, quality of life, sleep-quality, mortality, hospitaladmissions, length of stay and qualitative patient interviews.
Data from our completed trial study (NCT02667171) will be used as the opt-in PR comparison cohort.
- Conditions
- COPD
- Being tested
- No Intervention, just observation
- 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.
No Intervention, just observationOther
No Intervention, just observation
| Study group | Role | What they receive |
|---|---|---|
| Decliners of Pulmonary Rehabilitation | No intervention, just observation Receives: Other: No Intervention, just observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD Assessment Test (CAT)
Observation of changes in points. Lower score indicates improvement
Measured: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Secondary outcomes (15)
6-Minute Walk Test Distance (6MWD)
Observation of changes i meters. High is better
Measured: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Hospital Anxiety and Depression Scale (HADS)
Observation of changes in point. Low score is better
Measured: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Euro-Qol (EQ5D)
Observation of changes in Visual analogue scale (VAS). Higher VAS is better
Measured: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Brief Pain Inventory (BPI)
Observation of changes in points. Low is better
Measured: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Multidimensional Fatigue Inventory (MFI-20)
Observation of changes in points. Low is better
Measured: baseline and 52 weeks reassessment, (potentially 104 weeks reassesment)
Short Physical Performance Battery (SPPB)
Observation of changes in point. High is better
Measured: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Hand-Grip Strength (JAMAR)
Observation of changes in kilo. High is better
Measured: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
30 seconds sit-to-stand test (30sec-STS)
Observation of changes in repetitions. High is better
Measured: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Pittsburgh Sleep Quality Index (PSQI)
Observation of changes in point. Low score is better
Measured: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Number of hospital admissions (respiratory and all-cause)
Observation of changes in actual numbers. Low is better
Measured: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Length of hospital admissions (respiratory and all-cause)
Observation of changes in days. Low is better
Measured: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Out-patient visits
Observation of changes in actual number. Low is better
Measured: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Mortality (respiratory and all-cause)
Observation of changes as number of deaths. Low is better
Measured: baseline and 52 weeks reassessment, (potentially 104 weeks reassesment)
Timed Up and Go Test
Observation of changes in seconds. Low is better
Measured: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Activity level (ActivPAL)
Observation of changes in steps per day. High is better
Measured: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) - Worn by the patients around the clock for 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start1 Feb 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- Hillerod Hospital, Denmark, Herlev and Gentofte Hospital
- Responsible party
- Principal investigator, Henrik Hansen, Copenhagen University Hospital, Hvidovre
- Investigators
- Charlotte Suppli Ulrik, MD, DMSc, Study chair, Hvidovre University Hospital, Respiratory Department and Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249388
- Sponsor's protocol ID
- 19072886
- Acronym
- REPORT
- Status last verified
- May 2023
- First submitted
- 28 Jan 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Proposal for data use should be addressed to Henrik.hansen.09@regionh.dk Data access in Denmark are under very strict juristic data protection law. Any possible access or sharing demands a part application to 1. Danish Data Protection Agency, 2. Ethics Committee of the Capital Region 3. National Health Data Authorities. Only if the applications are approved data will be considered available for sharing. The authors will not be able to support this process and a prolonged process must be expected.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rethink Pulmonary Rehabilitation (REPORT Study)
- ClinicalTrials.gov ID
- NCT04249388
- Acronym / sponsor ID
- REPORT / 19072886
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- Hillerod Hospital, Denmark, Herlev and Gentofte Hospital
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 30 Jan 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.
Pulmonary rehabilitation (PR) is a cornerstone of care for people with COPD. There is robust evidence that PR improves exercise capacity, enhances health-related quality of life (QoL) and reduces healthcare utilization. PR is strongly recommended in guidelines for COPD management. Despite the compelling evidence for its benefits, PR is delivered to less than 30% of people with COPD. Access is particularly challenging, an especially for those with the most progressed disease stages.
We recently completed a randomized clinical trial, showing that approximately 1.100 patients annually are offered conventional hospital-based PR during routine consultations in the Capital Region of Denmark, but at least 700 patients declines participation.
No major cohort studies have been published from people with severe and advanced COPD who opt out of traditional pulmonary rehabilitation. By establishing such cohort study, objective and qualitative knowledge from assessments and patient interviews is collected in patients we have very limited access to and knowledge of. Additionally, the collected data will give a deeper insight and understanding and possibly enable us to design new delivery models to be tested in proper study designs.
Detailed description
Objective This cohort study aims to describe and understand differences and similarities in characteristics among people with severe and advanced COPD who opt-in or opt out of PR services.
The study includes data from: socio-demographic, anthropometric, physical (function, activity, muscle strength, balance) characteristics as well as self-reported symptoms of anxiety, depression, fatigue, pain, lung symptoms, quality of life, sleep-quality, mortality, hospitaladmissions, length of stay and qualitative patient interviews.
Data from our completed trial study (NCT02667171) will be used as the opt-in PR comparison cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decliners of Pulmonary Rehabilitation | – | Other: No Intervention, just observationNo intervention, just observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This is a prospective observational study of patients with COPD who declines participation in a conventional out-patient hospital-based PR program.
Key inclusion criteria (4 listed)
- Clinical diagnosis of COPD defined as a ratio of forced expiratory volume at one second (FEV1) to forced vital capacity < 0.70
- FEV1 <50%, corresponding to severe or very severe COPD
- Symptoms equivalent to the Medical Research Council (MRC) from 2 to 5
- Declines to participate in a conventional out-patient hospital-based PR program
Key exclusion criteria (5 listed)
- Concurrent participation in or recent completion of pulmonary rehabilitation within the last twelve months.
- Dementia/ Cognitive impairment or uncontrolled psychiatric illness,
- An impaired hearing and / or vision which causes the instructions in the assessment is not understood.
- language difficulties which causes inability to follow instruction or complete patient reported outcome measures (PROM.)
- Any comorbidity that are contraindicated to the assesment protocol.
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 |
|---|---|---|
| No Intervention, just observationNo Intervention, just observation | Other | Decliners of Pulmonary Rehabilitation |
Primary outcome
COPD Assessment Test (CAT)
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Observation of changes in points. Lower score indicates improvement
15 secondary outcomes
6-Minute Walk Test Distance (6MWD)
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Euro-Qol (EQ5D)
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Brief Pain Inventory (BPI)
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Multidimensional Fatigue Inventory (MFI-20)
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassesment)
Short Physical Performance Battery (SPPB)
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Hand-Grip Strength (JAMAR)
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
30 seconds sit-to-stand test (30sec-STS)
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Number of hospital admissions (respiratory and all-cause)
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Length of hospital admissions (respiratory and all-cause)
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Out-patient visits
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Mortality (respiratory and all-cause)
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassesment)
Timed Up and Go Test
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)
Activity level (ActivPAL)
Time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment) - Worn by the patients around the clock for 5 days
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 10 May 2023.
- Individual participant dataSharing planned: Yes. Proposal for data use should be addressed to Henrik.hansen.09@regionh.dk Data access in Denmark are under very strict juristic data protection law. Any possible access or sharing demands a part application to 1. Danish Data Protection Agency, 2. Ethics Committee of the Capital Region 3. National Health Data Authorities. Only if the applications are approved data will be considered available for sharing. The authors will not be able to support this process and a prolonged process must be expected.
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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.
Charlotte Suppli Ulrik, MD, DMSc study chair
Hvidovre University Hospital, Respiratory Department and Research Unit
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by University Hospital Bispebjerg and Frederiksberg at 4 sites 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 4 inclusion and 5 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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?
COPD Assessment Test (CAT) (time frame: baseline and 52 weeks reassessment, (potentially 104 weeks reassessment)). 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 10 May 2023.