RecruitingNot Applicable

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

Netherlands39 participantsStarted 2023-10-16

Plain-language 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.

Who can participate

Age range

7 Years – 15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Perception score

Timeframe: Two week run-in versus last week of intervention

Trial details

NCT IDNCT06702735

SponsorMedisch Spectrum Twente

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-01

Contact for this trial

Vera Hengeveld, MD

+31534872310 vera.hengeveld@mst.nl

View on ClinicalTrials.gov More Asthma in Children trials