COPD ExacerbationNCT04090671
Evaluation of the Multidimensional Dyspnea Profile (MDP)
A study testing Multidimensional Dyspnea Profile in people with COPD Exacerbation and CHF, run by Institut für Pneumologie Hagen Ambrock eV at 4 sites in Germany.
Trial summary
Aim of this multicenter prospective cohort study is the evaluation of the multidimensional qualities of dyspnea in a number of diseases using the Multidimensional Dyspnea Profile (Banzett et al, ERJ 2015). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation, CHF, OSA
- What is being tested?
- Multidimensional Dyspnea Profile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesGermany
- Study dates
- 19 Dec 2018to 1 Jan 2024
- 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 patients with acute exacerbation (Group I)
- CHF patients with acute decompensation (group II)
- stable COPD patients (group III)
- OSA patients with AHI>15 (group IV)
Who cannot join
- Other severe acute diseases that contradict the participation in a clinical trial
- Simultaneous participation in another clinical trial
- Not capable of giving consent
- Language abilities and other disabilities that contradicts the understanding or completing of a clinical questionnaire
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH
Essen, North Rhine-Westphalia, 45276
Helios Klinik Hagen Ambrock
Hagen, North Rhine-Westphalia, 58091
Märkische Kliniken GmbH, Klinikum Lüdenscheid
Lüdenscheid, North Rhine-Westphalia, 58515
Praxis Dr. med V. Jansen
Menden, North Rhine-Westphalia, 58706
About this study
Official title: Das Multidimensionale Dyspnoe Profil (MDP) Bei COPD, Herzinsuffizienz Und Schlafapnoe
Aim of this multicenter prospective cohort study is the evaluation of the multidimensional qualities of dyspnea in a number of diseases using the Multidimensional Dyspnea Profile (Banzett et al, ERJ 2015).
Read the detailed description
The study sites will examine patients with COPD (Chronic obstructive pulmonary disease) in state of acute exacerbation and in stable state, patients with congestive heart failure (CHF) in state of acute decompensated cardiac insufficiency, and patients newly diagnosed with obstructive sleep apnea (OSA) as a control group.
In the acute setting of COPD and CHF, the questionnaire will be given at the day of hospital admission and at the day of discharge. The patients will additionally fill the Severe Respiratory Insufficiency (SRI) Questionnaire (in COPD) or the Physical Activity Questionnaire 50+ (in CHF).
In stable state of COPD, the questionnaires will be given once during a routine control visit at the hospital or the medical practice.
In OSA, the questionnaire will be given once during the first visit in the sleep laboratory.
- Conditions
- COPD Exacerbation, CHF, OSA, COPD
- Being tested
- Multidimensional Dyspnea Profile
- Keywords
- Dyspnoea, MDP
- 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.
Multidimensional Dyspnea ProfileDiagnostic test
Also called MDP
The Multidimensional Dyspnea Profile measures the intensity of dyspneic breathing discomforts. It tests five sensory qualities that describe the patient's dyspnea in its respective intensity. Additionally it includes five potential reactions. The MDP is designed to refer to a specific event of time.
| Study group | Role | What they receive |
|---|---|---|
| COPD Exacerbation | Active comparator | the questionnaire MDP will be administered at the day of hospital admission and at the day of discharge. Receives: Diagnostic Test: Multidimensional Dyspnea Profile |
| CHF | Active comparator | the questionnaire MDP will be administered at the day of hospital admission and at the day of discharge. Receives: Diagnostic Test: Multidimensional Dyspnea Profile |
| COPD | Active comparator | In stable state of COPD, the questionnaire MDP will be administered once during a routine control visit at the hospital or the medical practice. Receives: Diagnostic Test: Multidimensional Dyspnea Profile |
| OSA | Active comparator | The questionnaire MDP will be administered once during the first visit in the sleep laboratory. Receives: Diagnostic Test: Multidimensional Dyspnea Profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDP scores during hospital stay
A1, Scale: Scale about breathing sensations with a defined start- and endpoint (neutral - unbearable). Values reach from 0-10, and higher values represent a worse outcome.
SQ1 (sensoric quality), Choice: 5 Phrases and terms about breathing sensations. Choose between yes and no and select one as "most accurately".
SQ2 (sensoric quality), Scales: 5 subscales about intensity of breathing sensations (muscle work; air hunger; chest tightness; mental effort; breathing a lot) with defined start- and endpoints (none - as intense as imaginable). Values reach from 0 - 10, and higher values represent a worse outcome.
A2 (emotional quality), Scales: 5 subscales about emotions (depressed, anxious, frustrated, angry, afraid) with defined start- and endpoints (none - as intense as imaginable). Values reach from 0 - 10, and higher values represent a worse outcome.
Measured: day 1 to day 5
Secondary outcomes (1)
comparison of MDP scores with clinical data
comparison of the A1 and A2 (scale 0-10) and SQ2 (scale 0-10) scores of the MDP between the diseases, the evaluation of dependencies of clinical routine data with the MDP scores
Measured: 1 to 5 (+- 3) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start19 Dec 2018
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- multicenter prospective cohort study
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Georg Nilius, Prof DR med, Kliniken Essen-Mitte
- Investigators
- Georg Nilius, Prof.Dr.med, Principal investigator, KEM Kliniken Essen-Mitte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090671
- Sponsor's protocol ID
- MDP2018
- Status last verified
- Jul 2023
- First submitted
- 12 Sep 2019
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- 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 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Das Multidimensionale Dyspnoe Profil (MDP) Bei COPD, Herzinsuffizienz Und Schlafapnoe
- ClinicalTrials.gov ID
- NCT04090671
- Acronym / sponsor ID
- MDP2018
- Conditions
- COPD Exacerbation, CHF, OSA, COPD
- Keywords
- Dyspnoea, MDP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eVIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 16 Sep 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.
Aim of this multicenter prospective cohort study is the evaluation of the multidimensional qualities of dyspnea in a number of diseases using the Multidimensional Dyspnea Profile (Banzett et al, ERJ 2015).
Detailed description
The study sites will examine patients with COPD (Chronic obstructive pulmonary disease) in state of acute exacerbation and in stable state, patients with congestive heart failure (CHF) in state of acute decompensated cardiac insufficiency, and patients newly diagnosed with obstructive sleep apnea (OSA) as a control group.
In the acute setting of COPD and CHF, the questionnaire will be given at the day of hospital admission and at the day of discharge. The patients will additionally fill the Severe Respiratory Insufficiency (SRI) Questionnaire (in COPD) or the Physical Activity Questionnaire 50+ (in CHF).
In stable state of COPD, the questionnaires will be given once during a routine control visit at the hospital or the medical practice.
In OSA, the questionnaire will be given once during the first visit in the sleep laboratory.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- multicenter prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| COPD Exacerbation | Active comparator | Diagnostic Test: Multidimensional Dyspnea Profilethe questionnaire MDP will be administered at the day of hospital admission and at the day of discharge. |
| CHF | Active comparator | Diagnostic Test: Multidimensional Dyspnea Profilethe questionnaire MDP will be administered at the day of hospital admission and at the day of discharge. |
| COPD | Active comparator | Diagnostic Test: Multidimensional Dyspnea ProfileIn stable state of COPD, the questionnaire MDP will be administered once during a routine control visit at the hospital or the medical practice. |
| OSA | Active comparator | Diagnostic Test: Multidimensional Dyspnea ProfileThe questionnaire MDP will be administered once during the first visit in the sleep laboratory. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD patients with acute exacerbation (Group I)
- CHF patients with acute decompensation (group II)
- stable COPD patients (group III)
- OSA patients with AHI>15 (group IV)
Key exclusion criteria (4 listed)
- Other severe acute diseases that contradict the participation in a clinical trial
- Simultaneous participation in another clinical trial
- Not capable of giving consent
- Language abilities and other disabilities that contradicts the understanding or completing of a clinical questionnaire
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 |
|---|---|---|
| Multidimensional Dyspnea ProfileAlso: MDPThe Multidimensional Dyspnea Profile measures the intensity of dyspneic breathing discomforts. It tests five sensory qualities that describe the patient's dyspnea in its respective intensity. Additionally it includes five potential reactions. The MDP is designed to refer to a specific event of time. | Diagnostic test | CHF, COPD, COPD Exacerbation, OSA |
Primary outcome
MDP scores during hospital stay
Time frame: day 1 to day 5
A1, Scale: Scale about breathing sensations with a defined start- and endpoint (neutral - unbearable). Values reach from 0-10, and higher values represent a worse outcome. SQ1 (sensoric quality), Choice: 5 Phrases and terms about breathing sensations. Choose between yes and no and select one as "most accurately". SQ2 (sensoric quality), Scales: 5 subscales about intensity of breathing sensations (muscle work; air hunger; chest tightness; mental effort; breathing a lot) with defined start- and endpoints (none - as intense as imaginable). Values reach from 0 - 10, and higher values represent a worse outcome. A2 (emotional quality), Scales: 5 subscales about emotions (depressed, anxious, frustrated, angry, afraid) with defined start- and endpoints (none - as intense as imaginable). Values reach from 0 - 10, and higher values represent a worse outcome.
1 secondary outcome
comparison of MDP scores with clinical data
Time frame: 1 to 5 (+- 3) days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- 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.
Georg Nilius, Prof.Dr.med principal investigator
KEM Kliniken Essen-Mitte
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidimensional Dyspnea Profile in people with COPD Exacerbation and CHF, run by Institut für Pneumologie Hagen Ambrock eV at 4 sites in Germany.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Jul 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 Germany. 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?
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?
MDP scores during hospital stay (time frame: day 1 to day 5). 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 14 Jul 2023.