Effects of the Kata® Inhalations-App on Inhaler Handling Errors, Adherence, and Asthma Control in Patients With Asthma.

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).

Conditions

• Asthma

Interventions

DEVICE

Kata Inhalations-App

The Kata Inhalations-App is a digital product that bears a CE mark. The application provides algorithms to run an inhalation trainer. The inhalation trainer shows patients how to improve their inhalation maneuver in a simple and understandable way. For this purpose, the signals from the camera and microphone of the patient's smartphone are used to evaluate the individual steps of the inhalation maneuver in real-time to provide automatic, personalized feedback. Additional functions of the Kata Inhalations-App include the possibility to document health parameters and to receive inhalation reminders. After set-up, subjects will use the application on their own as an add-on to their usual therapy for asthma. The total duration of application use will be 13 weeks, 1 week use of the Messinstrument ("Measurement")-App for all subjects (Baseline period), followed by 12 weeks use of the Kata Inhalations-App (intervention) or the Messinstrument-App (control).

Sponsors & Collaborators

• Thoraxklinik-Heidelberg gGmbH

  collaborator OTHER

• VisionHealth GmbH

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-20

Primary Completion

2025-01-14

Completion

2025-01-14

Countries

• Germany

Study Locations