Usual Medical Care
OtherProspective monitoring of clinical Outcomes and digital collected outcomes via the mobile COPD staus test app.
NCT Number: NCT04457843
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.
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Notify Me40 year–75 year
All sexes
Observational
Klinikum Nürnberg, Klinik für Innere Medizin3, Schwerpunkt Pneumologie, Nuremberg, Germany
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):
The mCST app takes about 15 minutes to complete.
Additionally, clinical routine data will be collected:
Study part II:
Visits 3 to 26 (week 3 to 26, in participants home environment) From study visit 3 on, participants are observed weekly in their home environment for a total of 24 weeks. No further clinic visits take place. Disease activity is measured weekly as patient reported outcomes using the mCST app (for details see description of visit 1/2, part 1). In addition to the weekly mCST app, patients are invited to fill out daily a symptom diary before going to bed. The symptom diary contains the EXACT questionnaire and an activity questionnaire.
*Visit 2 is optional
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prospective monitoring of clinical Outcomes and digital collected outcomes via the mobile COPD staus test app.
Time frame: Visit 1 (Day 0)
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)
Time frame: 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)
Time frame: weekly up to 26 weeks (Visit 1 to Visit 26)
Correlation between standardized questions about COPD activity/ symptoms via the mCST app and the COPD Assessment Test
Time frame: Visit 1 (Day 0)
Correlation between standardized questions about dyspnea collected via the mCST app and the modified medical research scale
Time frame: if applicable Visit 2 (Day 14)
Correlation between standardized questions about dyspnea collected via the mCST app and the modified medical research scale
Time frame: Visit 1 (Day 0)
Correlation between inspiratory-/ expiratory duration via the mCST app and FEV1, RV, TLC, VC
Time frame: if applicable Visit 2 (Day 14)
Correlation between inspiratory-/ expiratory duration via the mCST app and FEV1, RV, TLC, VC
Time frame: weekly up to 26 weeks (Visit 1 to Visit 26)
Correlation between standardized questions about COPD activity/symptoms via the mCST app and the EXACT questionnaire, which consists of 14 questions to quantify exacerbations.
Time frame: weekly up to 26 weeks (Visit 1 to Visit 26)
Correlation between standardized questions about COPD activity/ symptoms via the mCST app and the Freiburger activity questionnaire, which consists of 12 items and measures the duration and frequency of various basic, everyday and sports activities of the past week
Time frame: weekly up to 26 weeks (Visit 1 to Visit 26)
Change in the mCST app parameters during the trial period in stable COPD patients an COPD patients with an acute exacerbations during the study period
Schön Klinik Berchtesgadener Land
Other
The Mobile COPD Status Test (mCST) - Investigation of the Correlation of a Digital Measurement With Disease Relevant Endpoints in Patients With COPD
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