App-Based Education and Training Device for Inhaler Use in Asthma and COPD Patients Comparing App Support With Standard Care Over 6-12 Weeks

What this Trial Is About

Researchers are evaluating an app-based medical device designed to improve inhalation techniques in patients with asthma and COPD. The study aims to compare this app-based education and training with standard care over a 6-12 week period. The trial focuses on whether the app can increase the rate of successful inhalation techniques, which is important for effective treatment and symptom control in respiratory diseases. This research also assesses the feasibility, usability, and safety of the medical device during its use. Participants are randomly assigned to one of two groups one receiving standard care plus app-based education and training using the inhalation app-module embedded in the AsthmaTuner system, and the other receiving standard education without the app. The app uses a Bluetooth-connected spirometer and an adjustable resistance device to simulate inhaler resistance and measure inhalation flow. Training includes instructions, real-time feedback, and educational quizzes. Both groups receive initial inhalation technique assessment and training by a respiratory nurse, with follow-up at 6-12 weeks. During the study, participants use the app and device regularly to practice inhalation techniques. Researchers assess inhalation success by measuring peak inspiratory flow, time to peak flow, inhalation time, and breath holding, along with subjective criteria of correct device handling. Questionnaires and interviews collect data on the devices feasibility and patient experience. The main outcome is the rate of successful inhalation technique at the 6-12 week follow-up. The study involves 80 subjects aged 16 and older who use dry powder inhalers or metered dose inhalers daily for asthma or COPD.

APP-based Medical Device for Education and Training of Inhalation Technique