NCT06278662Recruiting
Cohort Multiple Randomized Controlled Trial in Pediatric Asthma
Cohort Multiple Randomized Controlled Trial in Pediatric Asthma: Infrastructure to Assess the Long- and Short-term Effects of (eHealth) Interventions.
Source: ClinicalTrials.gov · Last updated 26 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 12 Feb 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 1 Apr 2034
- Lead sponsor
- Mattienne van der Kamp
- Diseases
- Asthma
- NCT number
- NCT06278662
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 1 Apr 2024 to the primary completion date, 1 Apr 2034
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 4 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medisch Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.