Evaluation of the Multidimensional Dyspnea Profile (MDP)

Institut für Pneumologie Hagen Ambrock eV

Status: Active, not recruiting

Conditions: CHF; COPD; OSA; COPD Exacerbation

Treatments: Diagnostic Test: Multidimensional Dyspnea Profile

Study type: Interventional

Funder types: Industry

Identifiers

NCT04090671

MDP2018

Details and patient eligibility

About

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).

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 4 patient groups

COPD Exacerbation

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Multidimensional Dyspnea Profile

CHF

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Multidimensional Dyspnea Profile

COPD

Active Comparator group

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.

Treatment:

Diagnostic Test: Multidimensional Dyspnea Profile

OSA

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Multidimensional Dyspnea Profile