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Clinical efficacy and satisfaction of a digital wheeze detector in a multicentre randomised controlled trial: the
Yen Hoang Do1, Wim van Aalderen2, Ellen Dellbrügger3
1Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Insights
A digital wheeze detector (WheezeScan™) did not significantly improve wheeze control in preschool children at home. Further research is needed to understand how device use impacts clinical outcomes in managing childhood wheezing.
Area of Science:
- Pediatrics
- Digital Health
- Respiratory Medicine
Background:
- Wheezing is a common condition in preschool children, posing challenges for accurate clinical assessment by caregivers at home.
- The need for effective home-based tools to monitor and manage childhood wheezing is significant.
Purpose of the Study:
- To evaluate the impact of a novel digital wheeze detector, WheezeScan™, on disease control in preschool children within a home care setting.
- To assess the influence of the device on respiratory symptoms, quality of life, and caretaker self-efficacy.
Main Methods:
- A multicentre, randomised, open-label controlled trial involving 167 children aged 4-84 months with recurrent wheezing.
- The intervention group used the WheezeScan™ for 120 days, while the control group received usual care.
- Data on symptoms, quality of life, and self-efficacy were collected via questionnaires at baseline, 90 days, and 4 months.
Main Results:
- No statistically significant difference in wheeze control (primary outcome) was observed between the WheezeScan™ group and the control group at 90 days.
- Quality of life and parental self-efficacy remained comparable between groups.
- Parents reported the WheezeScan™ device as useful, indicating positive usability perceptions.
Conclusions:
- The digital wheeze detector did not demonstrate a significant impact on the home management of preschool wheezing in this study population.
- Further investigation is required to explore how user perception and behavior influence the clinical effectiveness of digital health support tools for wheezing management.
Introduction:
Wheezing is common in preschool children and its clinical assessment often challenging for caretakers. This study aims to evaluate the impact of a novel digital wheeze detector (WheezeScan™) on disease control in a home care setting.
Methods:
A multicentre randomised open-label controlled trial was conducted in Berlin, Istanbul and London. Participants aged 4-84 months with a doctor's diagnosis of recurrent wheezing in the past 12 months were included. While the control group followed usual care, the intervention group received the WheezeScan™ for at-home use for 120 days. Parents completed questionnaires regarding their child's respiratory symptoms, disease-related and parental quality of life, and caretaker self-efficacy at baseline (T0), 90 days (T1) and 4 months (T2).
Results:
A total of 167 children, with a mean±sd age of 3.2±1.6 years, were enrolled in the study (intervention group n=87; control group n=80). There was no statistically significant difference in wheeze control assessed by TRACK (mean difference 3.8, 95% CI -2.3-9.9; p=0.2) at T1 between treatment groups (primary outcome). Children's and parental quality of life and parental self-efficacy were comparable between both groups at T1. The evaluation of device usability and perception showed that parents found it useful.
Conclusion:
In the current study population, the wheeze detector did not show significant impact on the home management of preschool wheezing. Hence, further research is needed to better understand how the perception and usage behaviour may influence the clinical impact of a digital support.
