The Mobile COPD Status Test (mCST)

NCT04457843 | Completed

• 1 other identifier: mCST - Kaia App
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Telehealth; disease progression; disease activity

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (8)

• 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)

  Visit 1 (Day 0)

• 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)

  Visit 1 (Day 0)

• Correlation between lung function parameters and inspiratory-/expiratory duration measured via mobile COPD status test app (mCST)

  if applicable Visit 2 (Day 14)

Study Arms (1)

COPD patients

Other: usual medical care

Interventions

usual medical care OTHER

Prospective monitoring of clinical Outcomes and digital collected outcomes via the mobile COPD staus test app.

COPD patients

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

COPD patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead

Study Sites (2)

Klinikum Nürnberg, Klinik für Innere Medizin3, Schwerpunkt Pneumologie

Nuremberg, Germany

Location

Klinikum Berchtesgadener Land, Schön Kliniken

Schönau am Königssee, 83471, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Disease Progression

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor for pulmonary rehabilitation

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: July 7, 2020
• Study Start: August 21, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)