Cohort Multiple Randomized Controlled Trial in Pediatric Asthma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorMattienne van der Kamp

About this trial

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 criteria

Qualifiers

Is 4 to 18 years old

Is patient at the children's department at Medisch Spectrum Twente at moment of inclusion

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • video directly observed therapy (vDOT)

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mattienne van der Kamp

Lead sponsor

Medisch Spectrum Twente

Sponsor institution