A digital health assistant called Alex for children and teens with asthma
Tests a digital health assistant for asthma control in ages 10 to 19.
Plain-language title generated from the registry record
Registry title: Design, Development and Evaluation of a Digital Health Assistant for Paediatric Asthma
Key facts
- Where
- Brasov, Bucharest, Suceava, and Timișoara, RomaniaSee the 5 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 19 years old?
Source: NCT07472283, who can take part
Where in Romania
- Theramed Healthcare and Transylvania UniversityBrasov, RomaniaNo longer taking part
- University Carol Davila and Componenta de Pediatrie - Institutul Național pentru Sănătatea Mamei și Copilului "Alessandrescu-Rusescu" București (INSMC)Bucharest, RomaniaNo longer taking part
- Spitalul Judetean De UrgentaSuceava, RomaniaNo longer taking part
- Pediatric Pulmonology Clinic, County Hospital, Victor Babes University of MedicineTimișoara, RomaniaNo longer taking part
- Spitalul Clinic Judetean Timisoara and OncoGen Centre, Timisoara University of Medicine and Pharmacy Victor BabesTimișoara, RomaniaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Children's Hospital Basel
- Trial code
- NCT07472283
- Record updated
- 16 March 2026
- Original description
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.Read full original descriptionShow less
Design, Development and Evaluation of a Digital Health Assistant for Paediatric Asthma
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.
Inclusion: Written informed assent or consent, and parental/caregivers consent, depending on age; Age 10 to 19 years; Sufficient understanding of the Romanian language; Digital literacy, including the parents/caregivers, as assessed by the treating physician and/or by the recruiting healthcare provider using a multiple-choice questionnaire administered to the patient and their parents after a brief introduction to the functionalities of the Alex app; Confirmed asthma, i.e., history of recurrent wheeze, at least one spirometry in the three years prior to inclusion showing reversible obstruction (increase in forced expiratory volume at one second (FEV1) of ≥12% and/or ≥200ml) and/or a positive airway challenge test142; Participants need to be under treatment with regular prescribed asthma drugs, including inhaled corticosteroids, Long-acting β adrenoceptor agonists (LABA), and/or leukotriene receptor antagonists at recruitment, with no change in their medication in the last month; Enrolled in the observational study; Have had access to the DHA for at least 6 weeks; Provide informed assent (and parental/guardian consent where applicable) or consent, according to age; Able to participate in interviews or group discussions in Romanian.
Exclusion: Acute asthma exacerbation requiring systemic corticosteroids within four weeks prior to recruitment; Substance abuse as per urinary drug test; Qualitative study population:; Withdrawn from the observational study prior to data collection for qualitative work; Underlying chronic respiratory disease other than asthma (cystic fibrosis, primary ciliary dyskinesia); Acute lower respiratory tract infections (e.g., pneumonia, bronchitis) diagnosed by physician within past 4 to 6 weeks. For tuberculosis, see next exclusion criterion; Active tuberculosis as per Quantiferon test; Inability to perform adequate lung function measurements due to physical and/or intellectual disability; Not willing to use smartphones; Other causes of nocturnal cough such as postnasal drip, and vocal cord dysfunction; Active smoking as per urinary Cotinin test; Significant cognitive or communication difficulties that would limit participation in interviews or group discussions.
Observational study population:.