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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Netherlands
Medisch Spectrum Twente
RECRUITING
Enschede
Contact Information
Primary
CIRCUSstudy
circusstudie@mst.nl
+31 53 487 23 10
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2034-04-01
Participants
Target number of participants: 300
Treatments
Experimental: Intervention arm
The cohort multiple Randomised Controlled Trial (also known as TwiCs 'trials within cohorts') is a prospective study design in which (eHealth) intervention arms will be established over time. The interventions will be evaluated on the primary outcome measures of the cohort.
No_intervention: Cohort control group
Related Therapeutic Areas
Sponsors
Leads: Mattienne van der Kamp

This content was sourced from clinicaltrials.gov