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

Recruiting now · Not applicable

Conditions studied: Asthma in Children, Exercise Induced Asthma

In brief

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.

Key facts

Study ID

NCT06702735

Run by

Medisch Spectrum Twente

People needed

39

Starts

2023-10-16

Expected to finish

2025-05-01

Last updated by the study team

2024-11-25

Who can join

Age: 7 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Medisch Spectrum Twente — Enschede, Overijssel, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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