Effekte einer Smartphone-Applikation (Kaia COPD) zur selbstgerichteten pneumologischen Rehabilitation symptomatischer COPD-Patienten im häuslichen Umfeld - eine randomisierte, kontrollierte multizentrische und internationale klinische Studie

Group 1: Kaia COPD software application for self-management of pulmonary rehabilitation, on 3-7 days per week
Group 2: Active control group: physical activity, a brochure ?Besser leben mit COPD?, including written behavioural and exercise recommendations

Gender: All
Maximum age: None
Minimum age: 40 Years
Inclusion criteria: 1.Male and female patients =40 years of age
2.The patient is willing and able to sign informed consent for use of their pseudonymized clinical data within the scope of the present interventional trial
3.The patient is willing and able to comply with all-study related procedures, including conduction of the video-based 1MSTS in their home environment
4.Diagnosis of COPD, defined as forced expiratory volume in 1s/forced vital capacity (FEV1/FVC) <70% predicted, with or without chronic symptoms (cough, sputum production)
5.FEV1 post Bronchodilator (BD) = 30% predicted
6.CAT score of > 20 at baseline, indicating a high to very high COPD impact level
(after Protocol Amendment 1 DE: 19.01.2023
a) CAT assessment must be taken NOT earlier than 7 calendar days before the screening visit
b) Since CAT assessment:
- There were no changes in patient clinical status
- Patient had no exacerbations
- There were no changes in concomitant medication
c) The CAT assessment was done in writing, is dated and signed and kept as source data at the site.)
7.The patient?s pharmacologic treatment is stable and adherent to recommendations of current GOLD guidelines with no treatment changes in the past 4 weeks, except during a hospitalization with treatment adjustment
8.The patient is motivated to take part in exercise therapy
9.Stable internet access at home to use the application and ability to use the mobile application.
10.Knowledge of German language to understand study material, assessments and contents of the Kaia COPD-App

Exclusion criteria: 1.The Patient is not able to conduct the exercise training program due to physical, cognitive or safety reasons, as judged by investigator; e.g., lower limb joint surgery within preceding 3 months, unstable cardiac disease, predominant neurological limitations, planned surgical or other interventions disturbing the study intervention, such as LVRS or other surgical or interventional lung procedure in the past six months prior to enrolment
2.Use of Long-term oxygen therapy (LTOT) with flow rates higher than 3l/min or routine use of home non-invasive ventilation (NIV)
3.Significant psychiatric disorders, legal incapacity or limited legal capacity.
4.Participation in another clinical trial with an investigational medication or device within 30 days prior to study entry.
5.Participants already using a COPD self-management application or web-based program
6.Infection with COVID-19 during the trial or in the past six months prior to enrolment or residual symptoms of a COVID infection at baseline (not applicable anymore after Protocol Amendment 1 DE: 19.01.2023)
7.Current or planned participation in inpatient or outpatient pulmonary rehabilitation during the observational period