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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-19
SponsorUniversity Children's Hospital Basel

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Inability to perform adequate lung function measurements due to physical and/or intellectual disability.

Acute asthma exacerbation requiring systemic corticosteroids within four weeks prior to recruitment.

Not willing to use smartphones.

Underlying chronic respiratory disease other than asthma (cystic fibrosis, primary ciliary dyskinesia).

Trial design

Treatments tested in this trial

  • Phase I (months 1-3): DHA core functionality
  • Phase II (months 3-6): platform augmentation
  • Embedded qualitative study

Treatment groups

42 Participants
are divided into 1 treatment group

Sponsors and collaborators

University Children's Hospital Basel

Lead sponsor

Basel Research Center for Child Health

Collaborator