Actively Recruiting
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
Eligibility Criteria
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)
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
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands, 7512KZ
Actively Recruiting
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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