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NOT YET RECRUITING
NCT07472283

Design, Development and Evaluation of a Digital Health Assistant for Paediatric Asthma

Sponsor: University Children's Hospital Basel

View on ClinicalTrials.gov

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

Interventions

OTHER

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.

OTHER

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.

OTHER

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