Pediatric Asthma Study Using Multiple eHealth Interventions
Evaluating Long- and Short-Term Effects on Asthma Care and Quality of Life
For Children Ages 4 to 18 Treated at Medisch Spectrum Twente
Led by Mattienne van der Kamp · Updated on 2024-11-26
300
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to improve care for children with asthma by studying various eHealth interventions and their effects. The study uses a cohort multiple Randomized Controlled Trial cmRCT design to evaluate changes in quality of life, asthma control, lung function, quality of care, self-management skills, healthcare use, and therapy adherence in a group of children treated for asthma. It also seeks to develop patient risk profiles by considering personal, clinical, and environmental factors.
The study includes children aged 4 to 18 years diagnosed with asthma according to established guidelines and treated at a pediatric hospital. Participants remain in a cohort where some are randomly selected to receive eHealth interventions, such as video directly observed therapy vDOT, which involves daily recorded inhaler use and feedback sessions from an asthma nurse. Other children continue with usual outpatient care. The interventions are tested over time within the cohort framework.
Participants and their parents complete questionnaires on asthma control, quality of life, and self-management every month or every six months, depending on the measure. Researchers continuously collect clinical data and monitor healthcare use, medication delivery, and environmental factors like weather, air quality, and pollen daily. This monitoring continues until the child turns 18, no longer has an asthma diagnosis, or stops treatment at the hospital. The study aims to gather both short- and long-term data on asthma outcomes and care quality over a period of up to 14 years.
CONDITIONS
Brief Title
Cohort Multiple Randomized Controlled Trial in Pediatric Asthma
Research Team
C
CIRCUSstudy
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Is a patient at the children's department at Medisch Spectrum Twente at the time of inclusion
Diagnosed with asthma by a pediatrician following the Global Initiative for Asthma (GINA) guidelines 2022
Medical history fits asthma diagnosis including symptoms like wheezing, shortness of breath, or coughing triggered by infections, exercise, allergens, or weather changes
Spirometry shows variable expiratory airflow limitation by criteria such as reduced FEV1/FVC, positive bronchodilator response, positive exercise challenge test, or significant variation in lung function between tests
You will not qualify if you...
Child and/or parent(s) have insufficient command of the Dutch language resulting in inability to understand or answer study questions
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 168 months or until participant turns 18 years old, no longer has asthma diagnosis, or is no longer treated at MST hospital, whichever comes first.
Participants are observed with continuous collection of clinical data and completion of questionnaires to assess asthma control, quality of life, quality of care, self-management capacity, healthcare use, and environmental factors.
Monthly questionnaires and continuous data collection
Treatment
Duration - Duration according to the vDOT intervention schedule
A random selection of eligible participants receive video directly observed therapy (vDOT), involving daily recordings of inhalation use and four feedback sessions with an asthma nurse based on these recordings.
Daily recordings and 4 feedback sessions
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Published Research Related To This Trial
Cohort multiple randomized controlled trial in pediatric asthma to assess the long- and short-term effects of eHealth interventions: protocol of the CIRCUS study.