Evaluation of the Multidimensional Dyspnea Profile (MDP)

NCT04090671 | Unknown

• 1 other identifier: MDP2018
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

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).

Conditions

COPD Exacerbation; CHF; OSA; COPD

Keywords

Dyspnoea; MDP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• comparison of MDP scores with clinical data

  1 to 5 (+- 3) days

Study Arms (4)

COPD Exacerbation

ACTIVE COMPARATOR

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

Diagnostic Test: Multidimensional Dyspnea Profile

CHF

ACTIVE COMPARATOR

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

Diagnostic Test: Multidimensional Dyspnea Profile

COPD

ACTIVE COMPARATOR

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

OSA

ACTIVE COMPARATOR

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

Diagnostic Test: Multidimensional Dyspnea Profile

Interventions

Multidimensional Dyspnea Profile 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.

Also known as: MDP

CHF; COPD; COPD Exacerbation; OSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut für Pneumologie Hagen Ambrock eV: lead

Study Sites (4)

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

Essen, North Rhine-Westphalia, 45276, Germany

Location

Helios Klinik Hagen Ambrock

Hagen, North Rhine-Westphalia, 58091, Germany

Location

Märkische Kliniken GmbH, Klinikum Lüdenscheid

Lüdenscheid, North Rhine-Westphalia, 58515, Germany

Location

Praxis Dr. med V. Jansen

Menden, North Rhine-Westphalia, 58706, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Georg Nilius, Prof.Dr.med

  KEM Kliniken Essen-Mitte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: multicenter prospective cohort study

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: December 19, 2018
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)