Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Multidimensional Dyspnea Profile (MDP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04090671
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Georg Nilius, PD DR med, Kliniken Essen-Mitte

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).

Condition or disease Intervention/treatment Phase
COPD Exacerbation CHF OSA COPD Diagnostic Test: Multidimensional Dyspne Profile Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multicenter prospective cohort study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Das Multidimensionale Dyspnoe Profil (MDP) Bei COPD, Herzinsuffizienz Und Schlafapnoe
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: COPD Exacerbation
the questionnaire MDP will be administered at the day of hospital admission and at the day of discharge.
Diagnostic Test: Multidimensional Dyspne 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.
Other Name: MDP

Active Comparator: CHF
the questionnaire MDP will be administered at the day of hospital admission and at the day of discharge.
Diagnostic Test: Multidimensional Dyspne 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.
Other Name: MDP

Active Comparator: 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.
Diagnostic Test: Multidimensional Dyspne 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.
Other Name: MDP

Active Comparator: OSA
The questionnaire MDP will be administered once during the first visit in the sleep laboratory.
Diagnostic Test: Multidimensional Dyspne 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.
Other Name: MDP




Primary Outcome Measures :
  1. MDP scores longitudinal [ Time Frame: 5 days ]
    Main endpoint is the longitudinal comparison of the MDP scores between hospital admission and discharge

  2. comparison of MDP scores between COPD and CHF [ Time Frame: 5 days ]
    comparison between the COPD and the CHF group to identify the individual dyspnea symptoms.

  3. comparison of MDP scores between stable COPD and OSA [ Time Frame: 1 day ]
    comparison between the COPD and the OSA group as a control group


Secondary Outcome Measures :
  1. comparison of MDP scores with clinical data [ Time Frame: 1 to 5 days ]
    Secondary endpoints are a comparison of all MDP items between the diseases, the evaluation of dependencies of clinical routine data with the MDP scores.

  2. MCID [ Time Frame: 1 to 5 days ]
    an estimate of the minimal clinically important difference (MCID) of the various dyspnea dimensions in this patient groups.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090671


Contacts
Layout table for location contacts
Contact: Georg Nilius, Prof.Dr.med 0049 (0) 201 174 ext 22000 g.nilius@kem-med.com
Contact: Ulrike Domanski 0049 (0) 2331 974 ext 2080 ulrike.domanski@helios-gesundheit.de

Locations
Layout table for location information
Germany
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH Recruiting
Essen, NRW, Germany, 45276
Contact: Georg Nilius, Prof.Dr.med    0049 (0) 201 174 ext 22000    g.nilius@kem-med.com   
Contact: Ulrike Domanski    0049 (0) 2331 974 ext 2080    ulrike.domanski@helios-gesundheit.de   
Sub-Investigator: Alexander Stump         
Helios Klinik Hagen Ambrock Recruiting
Hagen, NRW, Germany, 58091
Contact: Wolfgang Galetke, Prof.Dr.med.    0049 2331 974 ext 2000    wolfgang.galetke@helios-gesundheit.de   
Contact: Ulrike Domanski    0049 (0) 2331 974 ext 2080    ulrike.domanski@helios-gesundheit.de   
Märkische Kliniken GmbH, Klinikum Lüdenscheid Recruiting
Lüdenscheid, NRW, Germany, 58515
Contact: Karl-Josef Franke, PD Dr.med    0049 2351 46 ext 3361    Karl-Josef.Franke@Klinikum-Luedenscheid.de   
Contact: Bald    0049 2351 46 ext 3361    Markus.Bald@klinikum-luedenscheid.de   
Sub-Investigator: Markus Bald         
Praxis Dr. med V. Jansen Recruiting
Menden, NRW, Germany, 58706
Contact: Volker Jansen, MD    0049 (0) 2373 ext 3234    info@lungenarzt-menden.de   
Contact: Ulrike Domanski    0049 (0) 2331 974 ext 2080    ulrike.domanski@helios-gesundheit.de   
Sponsors and Collaborators
Institut für Pneumologie Hagen Ambrock eV
Investigators
Layout table for investigator information
Principal Investigator: Georg Nilius, Prof.Dr.med KEM Kliniken Essen-Mitte

Layout table for additonal information
Responsible Party: Georg Nilius, PD DR med, Prof. Dr. med., Kliniken Essen-Mitte
ClinicalTrials.gov Identifier: NCT04090671     History of Changes
Other Study ID Numbers: MDP2018
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Georg Nilius, PD DR med, Kliniken Essen-Mitte:
Dyspnoea
MDP
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Disease, Chronic Obstructive
Dyspnea
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms