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Cohort multiple randomized controlled trial in pediatric asthma to assess the long- and short-term effects of eHealth

Tamara Ruuls1,2, Romi Sprengers3, Vera Hengeveld4,5

  • 1Pediatric Department, Medisch Spectrum Twente, Koningsplein 1, Enschede 7512 KZ, The Netherlands.

Therapeutic Advances in Respiratory Disease
|March 12, 2025
PubMed

Insights

This study introduces the CIRCUS trial, evaluating eHealth interventions for better pediatric asthma management. It aims to identify risk factors and personalized treatments for improved asthma control in children.

Area of Science:

  • Pediatric Pulmonology
  • Digital Health Interventions
  • Clinical Trial Design

Background:

  • Childhood asthma is a prevalent chronic condition with significant quality-of-life impacts.
  • Current asthma management often lacks real-time, objective monitoring, leading to uncontrolled symptoms.
  • eHealth interventions offer potential for timely symptom management and exacerbation prevention.

Purpose of the Study:

  • To present a pragmatic study design for longitudinal monitoring in pediatric asthma care.
  • To assess and compare the short- and long-term effects of eHealth interventions.
  • To gain insights into improving pediatric asthma management through technology.

Main Methods:

  • The CIRCUS study employs a cohort multiple randomized controlled trial (cmRCT) design.
  • A dynamic cohort of 300 pediatric asthma patients will be recruited.
  • Data collection includes observational and patient-reported outcomes, with random assignment to intervention or control groups.

Main Results:

  • Ethical approval was obtained from the Medical Research Ethics Committee on February 15th, 2024 (NL85668.100.23).
  • The study protocol is registered under NCT06278662 at ClinicalTrials.gov.

Conclusions:

  • The CIRCUS study will generate a unique dataset to identify asthma exacerbation risk factors and establish new clinical endpoints.
  • It will enable assessment and comparison of eHealth interventions for pediatric asthma care.
  • Findings will support tailoring eHealth solutions for personalized asthma management.
Abstract

Keywords:
asthmaclinical trial protocolcohort studiesinternet-based interventionpatient-reported outcome measurespediatricstelemedicine

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