Effects of the Kata® Inhalations-App on Inhaler Handling Errors, Adherence, and Asthma Control in Patients with Asthma.
- Conditions
- Asthma
- Interventions
- Device: Kata Inhalations-App
- Registration Number
- NCT06178341
- Lead Sponsor
- VisionHealth GmbH
- Brief Summary
The Kata® App is a digital therapy assistant for patients with asthma who need to inhale their therapy. Kata features inhalation trainers that shows patients in a simple and understandable way how to improve their inhalation maneuver so that the drug reaches the lungs efficiently. The Kata® App aims to reduce inhalation errors and ensures that inhaled drugs are used as approved and prescribed. Kata has different trainers for different inhalation devices. This study investigates the possible positive effects of the Kata® Inhalation App.
The main goal of the study is to:
1. investigate the effect of using the Kata® App on adherence for inhaled drugs in adult asthma patients. It consists of two parts: the correct use of the inhalers; and compliance with the therapy, or how much the patient follows the therapy plan as prescribed.
2. investigate the effect of using the Kata® App on asthma symptoms and asthma control, as measured by the Asthma Control Test (ACT) questionnaire.
In addition, asthma-related quality of life, lung function, and ease of use of the app will be assessed during the study.
This multicenter study follows a randomized, controlled, parallel-group, adaptive two-stage design. The study includes two different groups: an intervention and a control group. At the beginning of the study, each patient is randomly assigned to one of these two groups. The total duration of the study is 13 weeks: 1 baseline week and 12 intervention weeks. During the baseline week, the intervention and control group both use the app with limited functionality. Kata records their inhalations but does not provide inhalation training or feedback. This is to first assess how well patients are able to use their inhaler(s) without receiving support. After the first week, the intervention group starts using the app with full functionality for 12 weeks, which means that the app provides them with inhalation training and personalized feedback. The control group continues to use the app with limited functionality for 12 weeks, that means that they continue to use the app to record their inhalations but do not receive any inhalation training or feedback. This study will compare the patients in the intervention and control group, to find out the effect of using the Kata® inhalation app on the number of errors patients make when using their inhaler, therapy compliance, and health-related outcomes (asthma control, quality of life, and lung function).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Kata Inhalations-App Kata Inhalations-App with the following functions: 1. Inhalation reminder 2. Inhalation trainer 3. Health parameter documentation 4. Diary 5. Audio and video recording of user's inhalation maneuvers 6. Provision of study-specific questionnaires 7. Reminder to fill out study-specific questionnaires
- Primary Outcome Measures
Name Time Method Change in the average number of handling errors per inhalation compared between the intervention and control group Change in average number of handling errors per inhalation from baseline (study week 1) to the final intervention week (study week 13) Based on the recordings of the inhalation maneuvers from each data collection period, the inhaler handling and inhalation technique of each subject will be evaluated centrally by trained blinded personnel, based on the applicable German Airway League checklists for inhalation maneuvers (Checklisten Deutsche Atemwegsliga).
Change in Asthma Control Test (ACT) score compared between the intervention and control group Change in ACT score from baseline (study week 1) to the final intervention week (study week 13) The ACT consists of 5 questions (items) to assess the subject's asthma symptom control within the last 4 weeks. Each question can be answered on a 5-point numerical scale from 1 (worst) to 5 (best). The ACT score is the total score of all items. An ACT score of ≤ 15 points means "no asthma control", a score of 16 to 19 points means "partial asthma control" and a score of ≥ 20 points means "complete asthma control". These are the 3 ACT asthma control classes. The minimal clinically important difference for the ACT is 3 points.
The ACT will be completed during each data collection period. The questionnaire will be made available within the smartphone application. Subjects will be reminded to complete the ACT.
- Secondary Outcome Measures
Name Time Method Change in the Test of Adherence for Inhalers (TAI) score (patient domain) compared between the intervention and control group Change in TAI score from baseline (study week 1) to the final intervention week (study week 13) The TAI consists of 12 questions (items) to assess a subject's observance of inhalation therapy. The questions are grouped into 2 parts (domains) that can be scored and evaluated separately. In the 'patient domain', 10 items can be rated on a 5-point numerical scale from 1 (worst rating) to 5 (best rating). Based on the total score from those 10 questions, the extent of therapy observance (TAI adherence class) can be assessed: 50 points: adherent patients; 46 to 49 points: moderately adherent patients; ≤ 45 points: non-adherent patients. In the 'health professional domain', 2 items can be answered by choosing 1 of 2 options. The option associated with low therapy observance has a score of 1, while the option reflecting high therapy observance has a score of 2.
The TAI will be completed at Visit 1 and Visit 4. The questionnaire will be made available on paper. Subjects will complete the 'patient domain' while the Investigator will complete the 'health professional domain'.
Trial Locations
- Locations (13)
Thoraxklinik Heidelberg gGmbH
🇩🇪Heidelberg, Baden-Wuerttemberg, Germany
MVZ Dachau
🇩🇪Dachau, Bayern, Germany
Lunge im Zentrum
🇩🇪Erlangen, Bayern, Germany
Herzzentrum des Universitätsklinikums Bonn
🇩🇪Bonn, Germany
Lungenzentrum Darmstadt
🇩🇪Darmstadt, Germany
Studienzentrum Dr. Keller
🇩🇪Frankfurt am main, Germany
Marienkrankenhaus Kassel - Pneumologie
🇩🇪Kassel, Germany
Krankenhaus der Augustinerinnen
🇩🇪Köln, Germany
Allgemeinmedizin Untermenzing
🇩🇪München, Germany
Lungenarztpraxis Dr. med. Maria Weber
🇩🇪Wiesbaden, Germany
Lungenärzte am Rundfunkplatz
🇩🇪München, Germany
Facharztpraxis für Innere Medizin - Pneumologie - Allergologie
🇩🇪Oberursel, Germany
Pneumologische Praxis Wiesbaden
🇩🇪Wiesbaden, Germany