search
Back to results

Evaluation of the Multidimensional Dyspnea Profile (MDP)

Primary Purpose

COPD Exacerbation, CHF, OSA

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Multidimensional Dyspnea Profile
Sponsored by
Institut für Pneumologie Hagen Ambrock eV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COPD Exacerbation focused on measuring Dyspnoea, MDP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH
  • Helios Klinik Hagen Ambrock
  • Märkische Kliniken GmbH, Klinikum Lüdenscheid
  • Praxis Dr. med V. Jansen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

COPD Exacerbation

CHF

COPD

OSA

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2019
Last Updated
July 13, 2023
Sponsor
Institut für Pneumologie Hagen Ambrock eV
search

1. Study Identification

Unique Protocol Identification Number
NCT04090671
Brief Title
Evaluation of the Multidimensional Dyspnea Profile (MDP)
Official Title
Das Multidimensionale Dyspnoe Profil (MDP) Bei COPD, Herzinsuffizienz Und Schlafapnoe
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut für Pneumologie Hagen Ambrock eV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation, CHF, OSA, COPD
Keywords
Dyspnoea, MDP

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multicenter prospective cohort study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COPD Exacerbation
Arm Type
Active Comparator
Arm Description
the questionnaire MDP will be administered at the day of hospital admission and at the day of discharge.
Arm Title
CHF
Arm Type
Active Comparator
Arm Description
the questionnaire MDP will be administered at the day of hospital admission and at the day of discharge.
Arm Title
COPD
Arm Type
Active Comparator
Arm Description
In stable state of COPD, the questionnaire MDP will be administered once during a routine control visit at the hospital or the medical practice.
Arm Title
OSA
Arm Type
Active Comparator
Arm Description
The questionnaire MDP will be administered once during the first visit in the sleep laboratory.
Intervention Type
Diagnostic Test
Intervention Name(s)
Multidimensional Dyspnea Profile
Other Intervention Name(s)
MDP
Intervention Description
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.
Primary Outcome Measure Information:
Title
MDP scores during hospital stay
Description
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 Outcome Measure Information:
Title
comparison of MDP scores with clinical data
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Nilius, Prof.Dr.med
Organizational Affiliation
KEM Kliniken Essen-Mitte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH
City
Essen
State/Province
NRW
ZIP/Postal Code
45276
Country
Germany
Facility Name
Helios Klinik Hagen Ambrock
City
Hagen
State/Province
NRW
ZIP/Postal Code
58091
Country
Germany
Facility Name
Märkische Kliniken GmbH, Klinikum Lüdenscheid
City
Lüdenscheid
State/Province
NRW
ZIP/Postal Code
58515
Country
Germany
Facility Name
Praxis Dr. med V. Jansen
City
Menden
State/Province
NRW
ZIP/Postal Code
58706
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Multidimensional Dyspnea Profile (MDP)

We'll reach out to this number within 24 hrs