Evaluation of the Multidimensional Dyspnea Profile (MDP)

Institut für Pneumologie Hagen Ambrock eV400 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

400

Conditions

COPD Exacerbation CHF OSA COPD

Interventions

Multidimensional Dyspnea ProfileDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH

Essen, North Rhine-Westphalia, Germany

Helios Klinik Hagen Ambrock

Hagen, North Rhine-Westphalia, Germany

Märkische Kliniken GmbH, Klinikum Lüdenscheid

Lüdenscheid, North Rhine-Westphalia, Germany

Praxis Dr. med V. Jansen

Menden, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

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.

Time frame: day 1 to day 5

Secondary Outcomes

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

Time frame: 1 to 5 (+- 3) days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.