NCT06702735Recruiting
The Rainbow Study - the Effect of Feedback on Asthmatic Symptom Perception
The Rainbow Study - a Randomized Controlled Trial to Evaluate the Effect of Personalized Feedback on Symptom Perception in Asthmatic Children
Source: ClinicalTrials.gov · Last updated 25 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- First submitted
- 16 Oct 2023
- Start date
- 16 Oct 2023
- Primary completion date
- 1 Feb 2024
- Lead sponsor
- Medisch Spectrum Twente
- Diseases
- Asthma
- NCT number
- NCT06702735
What you commit to
- Study type: Interventional
- Planned participants: 39
- From 16 Oct 2023 to the primary completion date, 1 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medication change in past 2 weeks
Other illness
- Severe comorbidity (for example psychomotor retardation or severe cardiopulmonary conditions)
Other
- Not able to fill in VAS score (for example due to blindness)
- Not able to perform technically correct spirometry manoeuvres
- 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
Who the study is looking for
- 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)
Age in the registry: 7 years to 15 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medisch Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.