J44
Conditions
Interventions
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”, inc
Sponsors
Kaia Health Software GmbH
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
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) 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The two primary endpoints are change in health-related quality of life measured by change in CAT score from baseline and change in physical performance measured by change in number of repetitions of the 1MSTS from baseline after 90 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| All other endpoints are secondary endpoints. These are evaluated at regular intervals during the study and after a follow-up period 180 days after baseline measurement. The secondary endpoints are: - Health-related quality of life (VR-12) - Anxiety and depression (HADS) - Treatment motivation and activation (PAM 13-D) - Healthcare resource utilization - Treatment satisfaction and helpfulness - The adverse events (AEs) The AE of special interest (AESI): COVID-19 - The device deficiencies - Change in concomitant medication - 1MSTS and CAT score changes at the end of the additional follow-up period of 180 days Exploratory Objectives: As an exploratory objective, the incidence of mild, moderate or severe exacerbations (GOLD 2022) and the time from inclusion to the first exacerbation were assessed. As an additional exploratory objective, changes in app usage and associated physical activity were compared between participants that developed COVID-19 during the trial and those that did not. | — |
Countries
Germany, Switzerland
Contacts
Public ContactRembert Koczulla
Schön-Klinik Berchtesgadener Land
Outcome results
None listed