Cohort Multiple Randomized Controlled Trial in Pediatric Asthma

Recruiting now · Not applicable

Conditions studied: Pediatric Asthma

In brief

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).

Key facts

Study ID

NCT06278662

Run by

Mattienne van der Kamp

People needed

300

Starts

2024-04-01

Expected to finish

2034-04-01

Last updated by the study team

2024-11-26

Who can join

Age: 4 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

• Medisch Spectrum Twente — Enschede, Overijssel, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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