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CIRCUS

Cohort multiple Randomized Controlled trial in pediatric asthma: infrastructure to assess the long- and short-termeffects of (eHealth) interventions - CIRCUS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56556
Enrollment
300
Registered
2023-11-13
Start date
2024-03-27
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma, bronchial hyperreactivity Asthma

Interventions

The intervention consists of taking recording of daily inhalation use and receiving one to four feedback sessions of an asthma nurse based on these home recordings.

Sponsors

Medisch Spectrum Twente (MST)
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: CIRCUS cohort (n=300) -4 to 18 years old -patient at the children*s department at Medisch Spectrum Twente at moment of inclusion -diagnosed with asthma by a pediatrician following the Global Initiative for Asthma(GINA) guidelines 2022: 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 12%) Positive Exercise Challenge Test (ECT)(decrease FEV1>= 13%) Excessive variation in lung function (LF) between tests from different dates (variation FEV1>12% pred) For the MIME intervention (n=106, of which 30 intervention group, 76 control group): • Participating in CIRCUS cohort & consented willingness to participate in interventions. • ACT

Exclusion criteria

Exclusion criteria: For the CIRCUS cohort: 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 For the MIME study: • An appointment with the asthma nurse for inhalation instruction has already been scheduled.

Design outcomes

Primary

MeasureTime frame
CIRCUS: Primary outcome measures are Quality of life(QoL), asthma outcomes(asthma control, lung function), quality of care, selfmanagement capacity, healthcare use, and therapy compliance.Intervention 1 MIME: Asthma control, measured by the childhood Asthma control Test (if partidipant < 12 jaar) or the Astma Control Test (if participant >12 jaar) score.

Secondary

MeasureTime frame
CIRCUS: n/aIntervention 1 MIME: The secondary endpoint is the inhalation technique score within the intervention group, intervention adherence, intervention duration and participation rate.

Countries

Netherlands

Contacts

Public ContactM. R. Kamp

Medisch Spectrum Twente (MST)

m.vanderkamp@mst.nl0650070432

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026