Abstract
Background
Asthma is one of childhood's most prevalent chronic conditions that significantly impact the quality of life. Current asthma management lacks real-time, objective, and longitudinal monitoring reflected by a high prevalence of uncontrolled asthma (46–60%). Long-term (home) monitoring holds promise to establish new clinical endpoints for timely anticipation. Also, the integration of eHealth interventions holds promise for timely and appropriate medical anticipation for controlling symptoms and preventing asthma exacerbations. This study aims to provide a pragmatic study design for gaining insight into longitudinal monitoring, assessing, and comparing eHealth interventions' short- and long-term effects on improving pediatric asthma care.
Methods
For this cohort multiple randomized controlled trial (cmRCT), we establish a dynamic cohort of 300 pediatric asthma patients at Medisch Spectrum Twente (Enschede, the Netherlands), referred to as the CIRCUS cohort. The CIRCUS study gathers observational and patient-reported measurements at set moments, including patient characteristics, asthma outcomes, clinical outcomes, healthcare utilization, and environmental outcomes. We randomly appoint eligible participants to the intervention or control group. The effects of the eHealth interventions are assessed and compared to the control group, deploying the CIRCUS outcomes. The participants continue in the CIRCUS cohort after completing the intervention and its follow-up. This process repeats for every intervention, allowing re-approaching participants.
Discussion
The CIRCUS study results can provide a rich and unique data set that can improve insight into risk factors of asthma exacerbations and yield new clinical endpoints. Furthermore, the effects of eHealth interventions can be assessed and compared with each other in both the short- and long-term. Additionally, patient groups within the patient population can be discerned which can be used to tailor eHealth interventions to the personalized needs to improve asthma management. In conclusion, CIRCUS can provide valuable clinical data to discern risk factors for asthma exacerbations, identify and compare effective scalable eHealth solutions, and improve pediatric asthma care.
Trial Registration
This study was ethically approved by the Medical Research Ethics Committee (NL85668.100.23) on February 15th, 2024. The study protocol is registered at ClinicalTrials.gov (NCT06278662).