Actively Recruiting

Phase Not Applicable
Age: 4Years - 18Years
All Genders
NCT06278662

Cohort Multiple Randomized Controlled Trial in Pediatric Asthma

Led by Mattienne van der Kamp · Updated on 2024-11-26

300

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The overarching goal of this study is to optimize pediatric asthma care and to continuously evaluate variations/innovations of the care (including transformation to remote eHealth care). Primary Objectives within cmRCT cohort: * Provide a framework for multiple randomized (eHealth) interventions for asthmatic children * Generate short- and long-term data on Quality of life (QoL), asthma outcomes (asthma control, lung function), quality of care, self-management capacity, healthcare use, and therapy compliance in a representative secondary care pediatric asthma cohort. Secondary Objectives within cmRCT cohort: * Evaluate current pediatric asthma care at the Pediatric department of Medisch Spectrum Twente, in order to explore possible improvements for the pediatric asthma care. * Compare the short and long-term asthma outcomes between the eHealth care path and the outpatient care path. * Compose patient risk profiles that include both personal, clinical and exposome markers and clinical asthma endpoints (for example clinical admission/exacerbations).

CONDITIONS

Official Title

Cohort Multiple Randomized Controlled Trial in Pediatric Asthma

Who Can Participate

Age: 4Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Is 4 to 18 years old
  • Is a patient at the children's department at Medisch Spectrum Twente at the moment of inclusion
  • Has a diagnosis of asthma by a pediatrician following the Global Initiative for Asthma (GINA) guidelines 2022
  • Has a medical history fitting asthma diagnosis with symptoms such as nighttime wheezing, dyspnea, coughing triggered by viral infections, exercise, allergens, or weather changes
  • May have family history or atopy
  • Shows spirometry evidence of variable expiratory airflow limitation by at least one of these: reduced FEV1/FVC compared to lower limit of normal (Z-score ≤ -1.64), positive bronchodilator responsiveness (increase FEV1 >12%), positive Exercise Challenge Test (decrease FEV1 ≥13%), or excessive variation in lung function between tests (variation FEV1 >12% predicted)
Not Eligible

You will not qualify if you...

  • The child and/or parent(s) have insufficient command of the Dutch language resulting in insufficient ability to understand and/or answer questions

AI-Screening

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Trial Site Locations

Total: 1 location

1

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands, 7512KZ

Actively Recruiting

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Research Team

C

CIRCUSstudy

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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