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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Paediatric Asthma
• Intervention / Treatment: Other: Phase I (months 1-3): DHA core functionality; Other: Phase II (months 3-6): platform augmentation; Other: Embedded qualitative study

Detailed Description

This cohort study 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. The study is comprised of two phases:

In Phase I (months 1-3), Digital Health Assistant (DHA) 's core functionality will be deployed, i.e., 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, Digital Health Assistant 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 Digital Health Assistant on asthma control.

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.

In addition, 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.

• Study Type: Observational
• Enrollment (Estimated): 42

Contacts and Locations

• Study Contact: Name: Edgar Delgado-Eckert, Prof. Dr. med.; Phone Number: +41 61 704 18 37; Email: Edgar.Delgado-Eckert@ukbb.ch

Study Locations

• Romania
  • Brasov, Romania
    • Theramed Healthcare and Transylvania University
    • Contact: Ioana Agache
  • Bucharest, Romania
    • University Carol Davila and Componenta de Pediatrie - Institutul Național pentru Sănătatea Mamei și Copilului "Alessandrescu-Rusescu" București (INSMC)
    • Contact: Mihai Craiu
  • Suceava, Romania
    • Spitalul Judetean de Urgenta
    • Contact: Elena Tataranu
  • Timișoara, Romania
    • Pediatric Pulmonology Clinic, County Hospital, Victor Babes University of Medicine
    • Contact: Ioana Ciuca
  • Timișoara, Romania
    • Spitalul Clinic Judetean Timisoara and OncoGen Centre, Timisoara University of Medicine and Pharmacy Victor Babes
    • Contact: Carmen Bunu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

Observational study population:

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).
• 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 causes of nocturnal cough such as postnasal drip, and vocal cord dysfunction.
• Active smoking as per urinary Cotinin test.
• Substance abuse as per urinary drug test.

Qualitative study population:

Inclusion criteria:

• 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 criteria:

• Significant cognitive or communication difficulties that would limit participation in interviews or group discussions
• Withdrawn from the observational study prior to data collection for qualitative work

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational group; Patients will be handed out and instructed on the use of the hardware (smartphone, portable spirometer, smartwatch, and usage sensor for personal controller medication inhaler). The smartphone application Alex will be preinstalled on the smartphones.Participants and their parents/caregivers will be interviewed at inclusion to decide on the preferred type of incentives for preventing disengagement with the tele-monitoring system. 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	After 3 months relative to baseline (= Visit 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At Visit 2 (3 months after baseline), at Visit 3 (4.5 months after baseline),at Visit 4 (6 months after baseline)
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.	At 1.5 months, 3 months, 4.5 months and 6 months after baseline
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).	From Baseline to Visit 4 (6 months after baseline)
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).	From Baseline to Visit 4 (6 months after baseline)
Number of days of reliever (fast acting β-agonists) use	Number of days of reliever (fast acting β-agonists) use since last visit (as reported by the patient and/or their parents/caregivers).	From Baseline to Visit 4 (6 months after baseline)
Number of participants with one or more asthma exacerbations	Number of participants with one or more asthma exacerbations (as reported by the treating physician).	From Baseline to Visit 4 (6 months after baseline)
Absence from work the patient (as reported by the parents/caregivers).	Whether or not parents or caregivers were absent from work for one or more days since last visit due to health issues concerning the patient (as reported by the parents/caregivers).	From Baseline to Visit 4 (6 months after baseline)
Correlation between nocturnal breathing and nocturnal cough frequency measured passively using the smartphone and the smartwatch	Correlation between nocturnal breathing and nocturnal cough frequency measured passively using the smartphone and the smartwatch	From Baseline to Visit 4 (6 months after baseline)

Collaborators and Investigators

• Sponsor: University Children's Hospital Basel
• Collaborators: Basel Research Center for Child Health
• Investigators: Principal Investigator: Edgar Delgado-Eckert, Prof. Dr. med., University Children's Hospital at University of Basel, Basel, Switzerland; Principal Investigator: Torsten Schmitz Cherdron, Swiss Tropical and Public Health Institute (Swiss TPH), Basel, Switzerland; Principal Investigator: Filipe Da Conceicao Barata, Center for Digital Health Interventions at ETH Zurich, Zurich, Switzerland

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease (COPD); Asthma control; Gamification; Artificial Intelligence (AI); Digital health technologies; Digital Health Assistant (DHA); Fractional Exhaled Nitric Oxide (FeNo); Arterial blood oxygen saturation (SpO2); In-depth Interview (IDI); Focus Group Discussion (FGD)
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Study Characteristics; Clinical Trials as Topic; Clinical Studies as Topic; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic
• Other Study ID Numbers: ks25DelgadoEckert

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No