NCT07472283Not yet recruiting
Design, Development and Evaluation of a Digital Health Assistant for Paediatric Asthma
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 42 (estimated)
- First submitted
- 18 Feb 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 31 May 2027
- Lead sponsor
- University Children's Hospital Basel
- NCT number
- NCT07472283
What you commit to
- Study type: Observational
- Planned participants: 42
- From 1 Apr 2026 to the primary completion date, 31 May 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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- Withdrawn from the observational study prior to data collection for qualitative work
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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
Criteria the registry did not label
- Observational study population:
Age in the registry: 10 years to 19 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Theramed Healthcare and Transylvania University Coordinator of this site? Confirm its status | Brasov | Romania | Unknown status |
| University Carol Davila and Componenta de Pediatrie - Institutul Național pentru Sănătatea Mamei și Copilului "Alessandrescu-Rusescu" București (INSMC) Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Spitalul Judetean De Urgenta Coordinator of this site? Confirm its status | Suceava | Romania | Unknown status |
| Spitalul Clinic Judetean Timisoara and OncoGen Centre, Timisoara University of Medicine and Pharmacy Victor Babes Coordinator of this site? Confirm its status | Timișoara | Romania | Unknown status |
| Pediatric Pulmonology Clinic, County Hospital, Victor Babes University of Medicine Coordinator of this site? Confirm its status | Timișoara | Romania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.