Evaluation of the Multidimensional Dyspnea Profile (MDP)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Das Multidimensionale Dyspnoe Profil (MDP) Bei COPD, Herzinsuffizienz Und Schlafapnoe

Conditions
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COPD Exacerbation, CHF, OSA, COPD

Intervention / Treatment
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* Diagnostic Test: Multidimensional Dyspnea Profile


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multicenter prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: COPD Exacerbation<br>the questionnaire MDP will be administered at the day of hospital admission and at the day of discharge. | Diagnostic Test: Multidimensional Dyspnea Profile<br>* 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.<br>* Other names: MDP;|
| Active Comparator: CHF<br>the questionnaire MDP will be administered at the day of hospital admission and at the day of discharge. | Diagnostic Test: Multidimensional Dyspnea Profile<br>* 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.<br>* Other names: MDP;|
| Active Comparator: COPD<br>In stable state of COPD, the questionnaire MDP will be administered once during a routine control visit at the hospital or the medical practice. | Diagnostic Test: Multidimensional Dyspnea Profile<br>* 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.<br>* Other names: MDP;|
| Active Comparator: OSA<br>The questionnaire MDP will be administered once during the first visit in the sleep laboratory. | Diagnostic Test: Multidimensional Dyspnea Profile<br>* 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.<br>* Other names: MDP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | day 1 to day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 to 5 (+- 3) days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyspnoea, MDP