Optimizing asthma care for children using eHealth interventions
Cohort Multiple Randomized Controlled Trial in Pediatric Asthma: Infrastructure to Assess the Long- and Short-term Effects of (eHealth) Interventions.
This study tests whether using digital tools can improve asthma care for children aged 4-18 compared to regular doctor visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Sponsor | Medisch Spectrum Twente Academic / other |
| Locations | 1 site (Enschede, Overijssel) |
| Trial ID | NCT06278662 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance pediatric asthma management by implementing a cohort multiple randomized controlled trial (cmRCT) design to evaluate various eHealth interventions. It focuses on children aged 4-18 diagnosed with asthma, assessing both clinical outcomes and quality of life through regular questionnaires and observational data collection. The study compares the effectiveness of eHealth care pathways against traditional outpatient care, while also developing patient risk profiles based on personal and clinical markers. The goal is to provide real-time insights into asthma symptoms and improve overall care quality.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-18 years diagnosed with asthma according to GINA criteria and receiving treatment at Medisch Spectrum Twente.
Not a fit: Patients who do not speak Dutch or have insufficient language skills may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved asthma management and quality of life for pediatric patients.
How similar studies have performed: Other studies have shown promise in using eHealth interventions for asthma management, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 this trial is running
Enschede, Overijssel
- Medisch Spectrum Twente — Enschede, Overijssel, Netherlands (Recruiting)
Study contacts
- Study coordinator: CIRCUSstudy
- Email: circusstudie@mst.nl
- Phone: +31 53 487 23 10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.