Cohort Multiple Randomized Controlled Trial in Pediatric Asthma
Cohort Multiple Randomized Controlled Trial in Pediatric Asthma: Infrastructure to Assess the Long- and Short-term Effects of (eHealth) Interventions.
Mattienne van der Kamp
300 participants
Apr 1, 2024
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria12
- 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 Criteria1
- 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
Interventions
The first intervention of within the CIRCUS study is video directly observed therapy (vDOT). The intervention consists of taking recording of daily inhalation use and receiving four feedback sessions of an asthma nurse based on these home recordings.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06278662