Chronic Obstructive Pulmonary DiseaseNCT04457843
The Mobile COPD Status Test (mCST)
An observational study of Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- usual medical care
- How many people
- 130 participants
- Where
- 2 sitesGermany
- Study dates
- 21 Aug 2020to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Klinikum Nürnberg, Klinik für Innere Medizin3, Schwerpunkt Pneumologie
Nuremberg
Klinikum Berchtesgadener Land, Schön Kliniken
Schönau am Königssee, 83471
About this study
Official title: The Mobile COPD Status Test (mCST) - Investigation of the Correlation of a Digital Measurement With Disease Relevant Endpoints in Patients With COPD
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.
Read the detailed 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
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- usual medical care
- Keywords
- Telehealth, disease progression, disease activity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual medical careOther
Prospective monitoring of clinical Outcomes and digital collected outcomes via the mobile COPD staus test app.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Not described Receives: Other: usual medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Visit 1 (Day 0)
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)
Measured: if applicable Visit 2 (Day 14)
Secondary outcomes (8)
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
Measured: 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)
Correlation between standardized questions about dyspnea collected via the mCST app and the modified medical research scale
Measured: Visit 1 (Day 0)
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
Measured: if applicable Visit 2 (Day 14)
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
Measured: Visit 1 (Day 0)
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
Measured: if applicable Visit 2 (Day 14)
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.
Measured: weekly up to 26 weeks (Visit 1 to Visit 26)
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
Measured: 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
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
Measured: weekly up to 26 weeks (Visit 1 to Visit 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start21 Aug 2020
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Andreas Rembert Koczulla, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457843
- Sponsor's protocol ID
- mCST - Kaia App
- Status last verified
- Apr 2025
- First submitted
- 4 Jun 2020
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mobile COPD Status Test (mCST) - Investigation of the Correlation of a Digital Measurement With Disease Relevant Endpoints in Patients With COPD
- ClinicalTrials.gov ID
- NCT04457843
- Acronym / sponsor ID
- mCST - Kaia App
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Telehealth, disease progression, disease activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | Other: usual medical care |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| usual medical careProspective monitoring of clinical Outcomes and digital collected outcomes via the mobile COPD staus test app. | Other | COPD patients |
Primary outcome
Correlation between usual physical exercise tests and exercise test measured via mobile COPD status test app (mCST)
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)
Correlation between usual physical exercise tests and exercise test measured via mobile COPD status test app (mCST)
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)
8 secondary outcomes
Correlation between COPD Assessment test and perception of disease activity measured via mobile COPD status test app (mCST)
Time frame: 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)
Time frame: Visit 1 (Day 0)
Correlation between modified medical research scale (mMRc) and perception of dyspnea measured via mobile COPD status test app (mCST)
Time frame: if applicable Visit 2 (Day 14)
Correlation between lung function parameters and inspiratory-/expiratory duration measured via mobile COPD status test app (mCST)
Time frame: Visit 1 (Day 0)
Correlation between lung function parameters and inspiratory-/expiratory duration measured via mobile COPD status test app (mCST)
Time frame: if applicable Visit 2 (Day 14)
Correlation between mCST app and symptom diary (EXACT questionnaire)
Time frame: weekly up to 26 weeks (Visit 1 to Visit 26)
Correlation between mCST app and symptom diary (Freiburger activity questionnaire)
Time frame: 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
Time frame: weekly up to 26 weeks (Visit 1 to Visit 26)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Schön Klinik Berchtesgadener Land at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between usual physical exercise tests and exercise test measured via mobile COPD status test app (mCST) (time frame: Visit 1 (Day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025; AzTrials last refreshed its copy on 27 Oct 2026.