The Mobile COPD Status Test (mCST) - Investigation of the Correlation of a Digital Measurement With Disease Relevant Endpoints in Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Correlation between usual physical exercise tests and exercise test measured via mobile COPD status test app (mCST)
研究概览
简要总结
Up tp now, disease activity of COPD patients in their home environment has usually been recorded by questionnaires (e.g. COPD assessment test). Digital multifactorial measurements, via the "mobile COPD Status test" app, offer a new way of displaying disease activity. However, there is no independent study that has examined whether digitally collected parameters correlate with the common used measurement instruments for COPD patients (both in cross-sectional and longitudinal course).
The aim of this exploratory study is to investigate the correlation between the mobile COPD Status test (mCST App, KAIA Health) and a conventional collected clinical data set of routine measurements as well as the subjective symptoms and activity perception of COPD patients in their home environment, with and without exacerbation.
详细描述
In total 130 COPD patients will be included prospectively in this multicenter trial during an inpatient pulmonary rehabilitation program at the Schoen Klinik Berchtesgadener Land, Schönau am Koenigssee, (Germany) or during a stay (inpatient or outpatient) at the Klinikum Nuremberg (Germany).
In general, the study is divided into two parts - study part I, within the duration of the pulmonary rehabilitation program/ hospital stay and study part II, in the home environment (24 weeks).
Study part I:
Visit 1 (day 0, in the clinic) + Visit 2* (day 14+/-5, in the clinic/outpatient)
Each study participant is given a smartphone. Under the guidance of study personnel, data collection of the following parameters is carried out via KAIA mCST App):
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hospitalisation at Schoen Klinik Berchtesgadener Land or Klinikum Nuremberg
- •Chronic obstructive pulmonary disease GOLD A-D
- •sufficient german language and samrtphone skills to understand the mCST app
- •sufficient good WLAN Connection in the domestic environment
排除标准
- •presence of comorbidities which could interfere the course of the trial (e.g. cognitive deficits, neurological or orthopedic diseases)
- •significant mental illness, legal incapacity or limited legal capacity
- •patients who are unable or unwilling to perform the study activities acording to the protocol
结局指标
主要结局
Correlation between usual physical exercise tests and exercise test measured via mobile COPD status test app (mCST)
时间窗: if applicable Visit 2 (Day 14)
Correlation between the 6-minute walk test distance (clinical routine) and the number of repetitions of the 1-minute sit-to-stand-test (mCST app)
次要结局
- Correlation between COPD Assessment test and perception of disease activity measured via mobile COPD status test app (mCST)(weekly up to 26 weeks (Visit 1 to Visit 26))
- Correlation between modified medical research scale (mMRc) and perception of dyspnea measured via mobile COPD status test app (mCST)(if applicable Visit 2 (Day 14))
- Correlation between lung function parameters and inspiratory-/expiratory duration measured via mobile COPD status test app (mCST)(if applicable Visit 2 (Day 14))
- Correlation between mCST app and symptom diary (Freiburger activity questionnaire)(weekly up to 26 weeks (Visit 1 to Visit 26))
- Correlation between mCST app and symptom diary (EXACT questionnaire)(weekly up to 26 weeks (Visit 1 to Visit 26))
- Differences in outcomes of the mobile COPD status test app (mCST) between patients without and with exacerbations during the study period(weekly up to 26 weeks (Visit 1 to Visit 26))
研究者
Prof. Dr. Andreas Rembert Koczulla
Professor for pulmonary rehabilitation
Schön Klinik Berchtesgadener Land