Studies remote video-observed inhaler therapy in children with asthma
Compares remote video-observed inhaler care with usual clinic care in children with asthma.
Plain-language title generated from the registry record
Registry title: Cohort Multiple Randomized Controlled Trial in Pediatric Asthma
Key facts
- Where
- Enschede, NetherlandsSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 4 and 18 years old?
Source: NCT06278662, who can take part
Where in Netherlands
- Medisch Spectrum TwenteEnschede, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mattienne van der Kamp
- Trial code
- NCT06278662
- Record updated
- 26 November 2024
- Original description
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).Read full original descriptionShow less
Cohort Multiple Randomized Controlled Trial in Pediatric Asthma: Infrastructure to Assess the Long- and Short-term Effects of (eHealth) Interventions.
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).
Inclusion: 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: 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.