Evaluation of the Multidimensional Dyspnea Profile (MDP)

NCT ID: NCT04090671

Last Updated: 2023-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-19

Study Completion Date

2024-01-01

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.

Conditions

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COPD Exacerbation CHF OSA COPD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

multicenter prospective cohort study
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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COPD Exacerbation

the questionnaire MDP will be administered at the day of hospital admission and at the day of discharge.

Group Type ACTIVE_COMPARATOR

Multidimensional Dyspnea Profile

Intervention Type DIAGNOSTIC_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.

CHF

the questionnaire MDP will be administered at the day of hospital admission and at the day of discharge.

Group Type ACTIVE_COMPARATOR

Multidimensional Dyspnea Profile

Intervention Type DIAGNOSTIC_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.

COPD

In stable state of COPD, the questionnaire MDP will be administered once during a routine control visit at the hospital or the medical practice.

Group Type ACTIVE_COMPARATOR

Multidimensional Dyspnea Profile

Intervention Type DIAGNOSTIC_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.

OSA

The questionnaire MDP will be administered once during the first visit in the sleep laboratory.

Group Type ACTIVE_COMPARATOR

Multidimensional Dyspnea Profile

Intervention Type DIAGNOSTIC_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.

Interventions

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Multidimensional 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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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MDP

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut für Pneumologie Hagen Ambrock eV

INDUSTRY

Sponsor Role lead

Responsible Party

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Georg Nilius, Prof DR med

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georg Nilius, Prof.Dr.med

Role: PRINCIPAL_INVESTIGATOR

KEM Kliniken Essen-Mitte

Locations

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

Essen, North Rhine-Westphalia, Germany

Site Status

Helios Klinik Hagen Ambrock

Hagen, North Rhine-Westphalia, Germany

Site Status

Märkische Kliniken GmbH, Klinikum Lüdenscheid

Lüdenscheid, North Rhine-Westphalia, Germany

Site Status

Praxis Dr. med V. Jansen

Menden, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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MDP2018

Identifier Type: -

Identifier Source: org_study_id

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