Evaluation of the Multidimensional Dyspnea Profile (MDP)

Not Applicable

Active, not recruiting

• Conditions: CHF; OSA; COPD; COPD Exacerbation
• Interventions: Diagnostic Test: Multidimensional Dyspnea Profile

• Registration Number: NCT04090671
• Lead Sponsor: Institut für Pneumologie Hagen Ambrock eV

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.

Study Timeline

• Study Start: 2018-12-19
• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-16
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-14
• Primary Completion: 2023-12-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OSA	Multidimensional Dyspnea Profile	The questionnaire MDP will be administered once during the first visit in the sleep laboratory.
CHF	Multidimensional Dyspnea Profile	the questionnaire MDP will be administered at the day of hospital admission and at the day of discharge.
COPD	Multidimensional Dyspnea Profile	In stable state of COPD, the questionnaire MDP will be administered once during a routine control visit at the hospital or the medical practice.
COPD Exacerbation	Multidimensional Dyspnea Profile	the questionnaire MDP will be administered at the day of hospital admission and at the day of discharge.

Primary Outcome Measures

Name	Time	Method
MDP scores during hospital stay	day 1 to day 5	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

Name	Time	Method
comparison of MDP scores with clinical data	1 to 5 (+- 3) days	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

Trial Locations

Locations (4)

Praxis Dr. med V. Jansen; 🇩🇪 Menden, NRW, Germany

Helios Klinik Hagen Ambrock; 🇩🇪 Hagen, NRW, Germany

Märkische Kliniken GmbH, Klinikum Lüdenscheid; 🇩🇪 Lüdenscheid, NRW, Germany

Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH; 🇩🇪 Essen, NRW, Germany