Evaluation of the Multidimensional Dyspnea Profile (MDP)

COPD Clinical Trial

Official title:

Das Multidimensionale Dyspnoe Profil (MDP) Bei COPD, Herzinsuffizienz Und Schlafapnoe

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04090671
• Other study ID #: MDP2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 19, 2018
• Est. completion date: January 1, 2024

Study information

• Verified date: July 2023
• Source: Institut für Pneumologie Hagen Ambrock eV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: January 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CHF
• COPD
• COPD Exacerbation
• Dyspnea
• OSA
• Pulmonary Disease, Chronic Obstructive

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Germany	Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH	Essen	NRW
Germany	Helios Klinik Hagen Ambrock	Hagen	NRW
Germany	Märkische Kliniken GmbH, Klinikum Lüdenscheid	Lüdenscheid	NRW
Germany	Praxis Dr. med V. Jansen	Menden	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Institut für Pneumologie Hagen Ambrock eV

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	1 to 5 (+- 3) days