Cohort Multiple Randomized Controlled Trial in Pediatric Asthma
Recruiting · NCT06278662 · Interventional (participants receive a specific treatment) · Lead sponsor: Mattienne van der Kamp
View the official record on ClinicalTrials.gov →Interventions studied
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).
Who can take part
Inclusion criteria
- Is 4 to 18 years old
- Is patient at the children's department at Medisch Spectrum Twente at moment of inclusion
- Is diagnosed with asthma by a pediatrician following the Global Initiative for Asthma(GINA) guidelines 2022 \[8\]:
- \*Medical history fitting asthma diagnosis:
- Based on (typical) symptoms: (nighttime) wheezing, dyspnea, coughing (triggered by either viral infections, exercise, allergens or weather changes)
- (Possibly) supplemented with a family history/atopy
- AND
- \*Spirometry variable expiratory airflow limitation by at least one of these criteria:
- FEV1/FVC reduced compared to lower limit of normal(Z-score ≤ -1.64)
- Positive bronchodilator responsiveness(increase FEV1\>12%)
- Positive Exercise Challenge Test (ECT)(decrease FEV1≥ 13%)
- Excessive variation in lung function (LF) between tests from different dates (variation FEV1\>12% pred)
Exclusion criteria
- The child and/or parent(s) has/have insufficient command of the Dutch language resulting in the insufficient ability to understand and/or answer questions
Where it is running
1 location listed.
- Medisch Spectrum Twente - Enschede, Overijssel, Netherlands