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.
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.
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).
Adolescents, age 10 to 19 years, attending tertiary referral asthma clinics in the Romanian cities Brasov, Bucharest, Timisoara, and Suceava. For the Qualitative Substudy (IDIs and focus group discussions with adolescents), a sub-sample of participants from the observational study will be recruited, purposively selected to include roughly equal numbers of younger (10-14) and older (15-19) adolescents, as well as including both those that are identified as having higher and lower engagement, based on the app usage data.
Cohort
Prospective
Phase I (months 1-3): DHA core functionality
Other interventionActive 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
Other interventionPlatform 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
Other interventionAn 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.
Change in the asthma control questionnaire (ACQ) score
The Asthma Control Questionnaire (ACQ) measures asthma control over the past week, with scores ranging from 0 (well-controlled) to 6 (extremely poorly controlled).
Change in the asthma control questionnaire (ACQ) score
The Asthma Control Questionnaire (ACQ) measures asthma control over the past week, with scores ranging from 0 (well-controlled) to 6 (extremely poorly controlled).
Change in adherence to preventive inhaled corticosteroids
Adherence is defined as the proportion of preventer doses taken relative to the number of doses prescribed for a given time window.
Number of days off school
Proportion of days off school for any reason with respect to the total number of available official school days since last visit (as reported by the patient and/or their parents/caregivers).
Number of unplanned attendances to general practitioner/emergency department for asthma
Number of unplanned attendances to general practitioner/emergency department for asthma. since last visit (as reported by the patient and/or their parents/caregivers).
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University Children's Hospital Basel
Lead sponsor
Basel Research Center for Child Health
Collaborator
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