CHF, COPD, COPD Exacerbation, OSA
Conditions
Keywords
Dyspnoea, MDP
Brief 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).
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.
Interventions
DIAGNOSTIC_TESTMultidimensional Dyspnea Profile
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.
Sponsors
Institut für Pneumologie Hagen Ambrock eV
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
multicenter prospective cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MDP scores during hospital stay | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| comparison of MDP scores with clinical data | 1 to 5 (+- 3) days | 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 |
Countries
Germany
Outcome results
None listed