The Kaia COPD software Application: a digital therapeutic delivering PR to symptomatic COPD patients for self-management in the home setting – a randomized, controlled, multicentered and multinational clinical study.
Organizational Data
- DRKS-ID:
- DRKS00024390
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2021-05-26
- Last update in DRKS:
- 2024-01-11
- Registration type:
- Prospective
Acronym/abbreviation of the study
COPD-002 Koala Study
URL of the study
No Entry
Brief summary in lay language
With this study, we would like to investigate whether the use of a smartphone application (Kaia COPD) can improve the burden of symptoms and physical performance in people suffering from chronic obstructive pulmonary disease (COPD). Furthermore, we are interested in the effects on various factors such as quality of life, emotional state and health status as well as health care utilisation. For this purpose, we compare people who use the Kaia COPD app at home for half a year with people who do not use the Kaia COPD app and receive standard treatment.
Brief summary in scientific language
This study aims to evaluate the effect of a digital rehabilitation solution for patients with symptomatic COPD on physical performance (measured by 1MSTS) and health-related quality of life (measured by CAT) in patients with COPD over a 90-day period. The change in number of repetitions in 1MSTS and change in CAT score from baseline to day 90 in comparison to the control group (standard treatment) will be evaluated.
Health condition or problem studied
- ICD10:
- J44 - Other chronic obstructive pulmonary disease
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Kaia COPD software application for self-management of pulmonary rehabilitation, on 3-7 days per week
- Arm 2:
- Active control group: physical activity, a brochure “Besser leben mit COPD”, including written behavioural and exercise recommendations
Endpoints
- Primary outcome:
- 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 outcome:
- 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.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Data analyst
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Switzerland
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Doctor's practice Marburg
- Medical center Zürcher RehaZentrum Wald, Faltigbergstr. 7, 8636 Wald, Schweiz Ch-Wald
- Doctor's practice Berlin
- University medical center Klinik für Pneumologie am Universitätsklinikum Gießen und Marburg GmbH, Baldingerstraße, 35043 Marburg Marburg
- Medical center Schön Klinik Berchtesgadener Land, Malterhöh 1, 83471 Schönau am Königssee Schönau
- Medical center Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH, Wöhrendamm 80, 22927 Großhansdorf Grosshansdorf
- Medical center Thoraxklinik-Heidelberg gGmbH, Universitätsklinikum Heidelberg, Röntgenstr. 1, 69126 Heidelberg Heidelberg
- Other Hamburger Institut für Therapieforschung GmbH Colonnaden 72, 20354 Hamburg Hamburg
- University medical center Universitätsklinikum Frankfurt Studienambulanz Pneumologie, Theodor Stern Kai 7, 60590 Frankfurt Frankfurt
- Doctor's practice Konstanz
- Doctor's practice Erlangen
- Other KFGN - Klinische Forschung Hannover-Mitte GmbH, Schillerstraße 30, 30159 Hannover Hannover
- Other KFGN - Klinische Forschung Karlsruhe, Ettlinger-Tor-Platz 3, 76137 Karlsruhe Karlsruhe
- Other Klinische Forschung Berlin-Mitte GmbH, Georgenstraße 24, 10117 Berlin Berlin
- Other KLB Gesundheitsforschung Lübeck GmbH, Sandstr. 18, 23552 Lübeck Lübeck
- Medical center Klinik für Pneumologie Kantonsspital Winterthur, Brauerstrasse 15, 8400 Winterthur Ch-Wintherthur
- Other MECS Research GmbH, Mommsenstr. 2a, 12203 Berlin Berlin
- Doctor's practice Landsberg
Recruitment period and number of participants
- Planned study start date:
- 2021-05-31
- Actual study start date:
- 2021-05-26
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2023-05-22
- Target Sample Size:
- 278
- Final Sample Size:
- 278
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 40 Years
- Maximum Age:
- no maximum age
- Additional 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
Addresses
Primary Sponsor
- Address:
- Kaia Health Software GmbHAsta StankevicieneHerzog-Wilhelm-Straße 2680331 MünchenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Schön-Klinik Berchtesgadener LandProf. Dr. Rembert KoczullaMalterhöh 183471 Schönau am KönigsseeGermany
- Telephone:
- 08652 930
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Schön-Klinik Berchtesgadener LandProf. Dr. Rembert KoczullaMalterhöh 183471 Schönau am KönigsseeGermany
- Telephone:
- 08652 930
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Schön-Klinik Berchtesgadener LandProf. Dr. Rembert KoczullaMalterhöh 183471 Schönau am KönigsseeGermany
- Telephone:
- 08652 930
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Kaia Health Software GmbHHerzog-Wilhelm-Straße 2680331 MünchenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikommission Fachbereich Medizin der Philipps-Universität MarburgBaldingerstr. 135032 MarburgGermany
- Telephone:
- +49-6421-5866487
- Fax:
- +49-6421-5866585
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-02-10
- Ethics committee number:
- 32/21
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-04-26
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- Date of Original Protocol v1.1: 25 MAR 2021; Date of Protocol Amendment 1 DE: 19 JAN 2023
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry