The Mobile COPD Status Test (mCST)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The Mobile COPD Status Test (mCST) - Investigation of the Correlation of a Digital Measurement With Disease Relevant Endpoints in Patients With COPD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04457843
• Other study ID #: mCST - Kaia App
• Status: Active, not recruiting
• Start date: August 21, 2020
• Est. completion date: June 2023

Study information

• Verified date: March 2023
• Source: Schön Klinik Berchtesgadener Land
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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):

• four standardized questions regarding coughing frequency, expectoration, chest tightness and shortness of breath during exercise

• Dyspnea at rest

• Breath sounds via microphone

• Inspiration/expiration length via microphone

• Respiratory rate via smartphone measurements

• Physical performance via the sit-to-stand test (1min) with counting the repetitions and checking the correct execution via smartphone camera

• Gait analysis (2x 10 steps walking) via acceleration sensors of the smartphone or via motion tracking by camera during defined gait measurements.

The mCST app takes about 15 minutes to complete.

Additionally, clinical routine data will be collected:

• medical history

• body plethysmography & blood gases

• EKG

• health related quality of life

• dyspnea

• 6-minute walk distance

• 1-minute-sit to stand test

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: June 2023
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• usual medical care
Prospective monitoring of clinical Outcomes and digital collected outcomes via the mobile COPD staus test app.

Locations

Country	Name	City	State
Germany	Klinikum Nürnberg, Klinik für Innere Medizin3, Schwerpunkt Pneumologie	Nürnberg
Germany	Klinikum Berchtesgadener Land, Schön Kliniken	Schönau am Königssee

Sponsors (1)

Lead Sponsor	Collaborator
Schön Klinik Berchtesgadener Land

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between usual physical exercise tests and exercise test measured via mobile COPD status test app (mCST)	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)	Visit 1 (Day 0)
Primary	Correlation between usual physical exercise tests and exercise test measured via mobile COPD status test app (mCST)	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)	if applicable Visit 2 (Day 14)
Secondary	Correlation between COPD Assessment test and perception of disease activity measured via mobile COPD status test app (mCST)	Correlation between standardized questions about COPD activity/ symptoms via the mCST app and the COPD Assessment Test	weekly up to 26 weeks (Visit 1 to Visit 26)
Secondary	Correlation between modified medical research scale (mMRc) and perception of dyspnea measured via mobile COPD status test app (mCST)	Correlation between standardized questions about dyspnea collected via the mCST app and the modified medical research scale	Visit 1 (Day 0)
Secondary	Correlation between modified medical research scale (mMRc) and perception of dyspnea measured via mobile COPD status test app (mCST)	Correlation between standardized questions about dyspnea collected via the mCST app and the modified medical research scale	if applicable Visit 2 (Day 14)
Secondary	Correlation between lung function parameters and inspiratory-/expiratory duration measured via mobile COPD status test app (mCST)	Correlation between inspiratory-/ expiratory duration via the mCST app and FEV1, RV, TLC, VC	Visit 1 (Day 0)
Secondary	Correlation between lung function parameters and inspiratory-/expiratory duration measured via mobile COPD status test app (mCST)	Correlation between inspiratory-/ expiratory duration via the mCST app and FEV1, RV, TLC, VC	if applicable Visit 2 (Day 14)
Secondary	Correlation between mCST app and symptom diary (EXACT questionnaire)	Correlation between standardized questions about COPD activity/symptoms via the mCST app and the EXACT questionnaire, which consists of 14 questions to quantify exacerbations.	weekly up to 26 weeks (Visit 1 to Visit 26)
Secondary	Correlation between mCST app and symptom diary (Freiburger activity questionnaire)	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	weekly up to 26 weeks (Visit 1 to Visit 26)
Secondary	Differences in outcomes of the mobile COPD status test app (mCST) between patients without and with exacerbations during the study period	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	weekly up to 26 weeks (Visit 1 to Visit 26)