Clinical efficacy and satisfaction of a digital wheeze detector in a multicentre randomised controlled trial: the WheezeScan study

Abstract

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.

FIGURE 1

Consort chart with inclusion criteria, recruitment, study design and timeline. GINA: Global Initiative for Asthma.

FIGURE 2

Individual measures of wheeze control (TRACK) at baseline (T0: baseline) and follow-up (T1: 90 days) for the intervention (n=78) and control group (n=72).

FIGURE 3

Proportion of well-controlled (TRACK ≥80 points) and not well-controlled (TRACK <80 points) by study group (control group n=80, intervention group n=87) and time point. Total number of participants in each TRACK group per treatment group per time point are shown at the top of each section of the bar plot.

FIGURE 4

a–d) Wheeze control (TRACK), disease-specific quality of life (TAPQOL), parental quality of life (PACQLQ) and parental asthma management self-efficacy (PAMSES) by study groups (control group n=80, intervention group n=87) and time points (T0: baseline and T1: 90 days) depicted as box plots/rain cloud plots. e–h) Additionally, estimated marginal means using linear regression models are shown by group at T1 (90 days) with 95% CI.