Das Multidimensionale Dyspnoe Profil (MDP) Bei COPD, Herzinsuffizienz Und Schlafapnoe
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 8
- 主要终点
- MDP scores during hospital stay
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
MDP scores during hospital stay
时间窗: 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.
次要结局
- comparison of MDP scores with clinical data(1 to 5 (+- 3) days)
研究者
Georg Nilius, Prof DR med
Prof. Dr. med.
Kliniken Essen-Mitte