Clinical Trials in the Netherlands / NCT06702735
Recruiting Not applicable

The Rainbow Study - the Effect of Feedback on Asthmatic Symptom Perception

NCT06702735 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2023-10-16
Last updated
2024-11-25

Condition(s) studied

Asthma in ChildrenExercise Induced Asthma

Investigational drug(s) / intervention(s)

Rainbow toolFeedback

Rainbow tool: The Rainbow tool visualizes perception based on lung function measurements and VAS scores.

Feedback: Feedback sessions with health care professional based on the Rainbow tool.

Study summary

Asthma is a common childhood disease that is characterized by chronic airway inflammation and episodic expiratory airflow obstruction. Asthma symptoms can impair participation in play and sports and have a negative impact on quality of life. It can be challenging for children to adequately feel and report their symptoms. Some children experience more symptoms than expected based on lung function during these symptoms, whereas others experience less symptoms than expected. This is also called 'symptom perception'.

A tool was developed to visualize symptoms, lung function and accessory symptom perception: The Rainbow tool. The aim of this study was to identify asthmatic children with a poor perception and investigate if their symptom perception could be improved by regular lung function measurements and personal feedback based on the Rainbow Tool.

Hypothesis: Measuring lung function en symptoms and provide personal feedback on perception based on the Rainbow tool has a positive effect on perception of asthma-related symptoms in asthmatic children.

Eligibility

Sex
ALL
Min age
7 Years
Max age
15 Years
Healthy volunteers
No
Inclusion Criteria: Selection phase: * Pediatrician diagnosed asthma * Health care professional thinks perception might be poor * Age 7 until 15 years old * Adequate understanding of Dutch language Intervention phase: * Adequate number of lung function measurements + VAS scores during selection phase, defined as: * At least 4 measurements after exercise or when experiencing symptoms and * At least 2 standard measurements * Poor perception during selection phase, defined as: * At least 1 measurement in red zone on Perception Rainbow and/or * At least 2 measurements in orange zone on Perception Rainbow and/or * Average of all measurements after exercise or when experiencing symptoms in yellow zone (or orange/red)and/or * Average of all measurements in yellow zone (or orange/red) Exclusion Criteria: * Severe comorbidity (for example psychomotor retardation or severe cardiopulmonary conditions) * Not able to fill in VAS score (for example due to blindness) * Not able to perform technically correct spirometry manoeuvres * Medication change in past 2 weeks * Exacerbation which required oral prednisone in the past 6 weeks * Exacerbation at the moment of inclusion * No device (computer, tablet or smartphone) with internet connection available at home

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Medisch Spectrum Twente Enschede Overijssel Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06702735 on ClinicalTrials.gov ↗ ← All trials in the Netherlands