Cohort Multiple Randomized Controlled Trial in Pediatric Asthma: Infrastructure to Assess the Long- and Short-term Effects of (eHealth) Interventions.

What this Trial Is About

This research aims to improve care for children with asthma by studying various eHealth interventions and their effects. The study uses a cohort multiple Randomized Controlled Trial (cmRCT) design to evaluate changes in quality of life, asthma control, lung function, quality of care, self-management skills, healthcare use, and therapy adherence in a group of children treated for asthma. It also seeks to develop patient risk profiles by considering personal, clinical, and environmental factors. The study includes children aged 4 to 18 years diagnosed with asthma according to established guidelines and treated at a pediatric hospital. Participants remain in a cohort where some are randomly selected to receive eHealth interventions, such as video directly observed therapy (vDOT), which involves daily recorded inhaler use and feedback sessions from an asthma nurse. Other children continue with usual outpatient care. The interventions are tested over time within the cohort framework. Participants and their parents complete questionnaires on asthma control, quality of life, and self-management every month or every six months, depending on the measure. Researchers continuously collect clinical data and monitor healthcare use, medication delivery, and environmental factors like weather, air quality, and pollen daily. This monitoring continues until the child turns 18, no longer has an asthma diagnosis, or stops treatment at the hospital. The study aims to gather both short- and long-term data on asthma outcomes and care quality over a period of up to 14 years.

Cohort Multiple Randomized Controlled Trial in Pediatric Asthma