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Design, Development and Evaluation of a Digital Health Assistant for Paediatric Asthma
Sponsor: University Children's Hospital Basel
Summary
This study is to evaluate the efficacy of the digital health assistant (DHA) "Alex" in improving asthma control in asthmatic children and adolescents aged 10 to 19 compared to their baseline values. It is designed to track over a period of six consecutive months lung function parameters, lung inflammation, asthma symptoms and burden, medication adherence, and passively recorded nocturnal asthma symptoms and markers related to sleep quality. In Phase I (months 1-3), Digital Health Assistant (DHA) 's core functionality will be deployed. In Phase II (months 3-6), the platform will be augmented with lung-function-fluctuations analysis-informed therapeutic recommendations, allowing to quantify the incremental benefit of targeted decision support beyond the gamified DHA alone. An embedded qualitative study will be conducted to evaluate acceptability of and engagement with the DHA.
Key Details
Gender
All
Age Range
10 Years - 19 Years
Study Type
OBSERVATIONAL
Enrollment
42
Start Date
2026-04
Completion Date
2027-05
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
Phase I (months 1-3): DHA core functionality
Active collection of daily lung function, and fortnightly administration of the Asthma Control Questionnaire (ACQ), together with passive monitoring of controller asthma medication use and nocturnal physiological metrics (respiratory rate, SpO₂, heart rate, cough frequency) via inhaler sensor, smartwatch and bedside microphone. Moreover, ALEX will act as an engagement/adherence enhancing patient coach, providing behavioral economics informed reminders and incentives, and educational materials on asthma and asthma treatment. This phase will enable to determine the effect of these core features of the DHA on asthma control.
Phase II (months 3-6): platform augmentation
Platform augmentation with lung-function-fluctuations analysis-informed therapeutic recommendations, allowing to quantify the incremental benefit of targeted decision support beyond the gamified DHA alone.
Embedded qualitative study
An embedded qualitative study will be conducted to evaluate acceptability of and engagement with the DHA. This will include in-depth interviews (IDIs) with adolescents and focus group discussions (FGDs) with adolescents and healthcare providers.
Locations (5)
Theramed Healthcare and Transylvania University
Brasov, Romania
University Carol Davila and Componenta de Pediatrie - Institutul Național pentru Sănătatea Mamei și Copilului "Alessandrescu-Rusescu" București (INSMC)
Bucharest, Romania
Spitalul Judetean De Urgenta
Suceava, Romania
Pediatric Pulmonology Clinic, County Hospital, Victor Babes University of Medicine
Timișoara, Romania
Spitalul Clinic Judetean Timisoara and OncoGen Centre, Timisoara University of Medicine and Pharmacy Victor Babes
Timișoara, Romania