Improving asthma symptom perception in children using a feedback tool
The Rainbow Study - a Randomized Controlled Trial to Evaluate the Effect of Personalized Feedback on Symptom Perception in Asthmatic Children
NA · Medisch Spectrum Twente · NCT06702735
This study is testing a new tool to help kids aged 7 to 15 understand their asthma symptoms better so they can manage their condition more effectively.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 7 Years to 15 Years |
| Sex | All |
| Sponsor | Medisch Spectrum Twente (other) |
| Drugs / interventions | prednisone |
| Locations | 1 site (Enschede, Overijssel) |
| Trial ID | NCT06702735 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the understanding of asthma symptoms in children aged 7 to 15 by utilizing the Rainbow tool, which visualizes the relationship between lung function and symptom perception. The study involves regular lung function measurements and personalized feedback to help children better recognize and report their symptoms. By identifying children with poor symptom perception, the study seeks to improve their ability to manage asthma effectively. The approach is designed to empower young patients through better awareness of their condition.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 7 to 15 diagnosed with asthma who may have poor symptom perception.
Not a fit: Patients with severe comorbidities or those unable to understand or complete the required assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved asthma management and quality of life for children by enhancing their ability to perceive and respond to their symptoms.
How similar studies have performed: While the specific use of the Rainbow tool is novel, similar approaches focusing on symptom perception in asthma have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Enschede, Overijssel
- Medisch Spectrum Twente — Enschede, Overijssel, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Vera Hengeveld, MD — Medisch Spectrum Twente
- Study coordinator: Vera Hengeveld, MD
- Email: vera.hengeveld@mst.nl
- Phone: +31534872310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Asthma in Children, Exercise Induced Asthma