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Recruiting NCT06702735

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

No phase Interventional Asthma in Children Exercise Induced Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rainbow tool, Feedback.
Who it may be relevant to
Registry conditions: Asthma in Children, Exercise Induced Asthma. Basic parameters: 7 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Rainbow Study - a Randomized Controlled Trial to Evaluate the Effect of Personalized Feedback on Symptom Perception in Asthmatic Children

Overview

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.

Detailed description

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 Rainbow tool is a two-dimensional color-coded plot, visualizing the relationship between lung function, denoted as a percentage of personal best (FEV1) on the vertical axis, and VAS score on the horizontal axis. The FEV1 as a percentage of personal best on the vertical axis ranges from 30% to 100% since a maximal VAS score would be expected with a change in FEV1 to ≤ 30% of personal best. The horizontal axis ranges from 0 to 10, with 0 indicating no dyspnea and 10 maximal dyspnea. There are four color-coded zones: the green zone, yellow zone, orange zone, and red zone. The green zone indicates good alignment between symptoms and lung function, and thus a good symptom perception. It forms a diagonal band from the upper left (around 100% FEV1 and VAS score of 0) stretching to the lower right (around 30% FEV1 and VAS score of 10). The green zone is followed by the yellow, orange, and red zones on either side, indicating an increasing deviation in symptom perception from the ideal and respectively mild, moderate, and severe disconcordance between FEV1 and VAS score. 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.

Interventions

  • Behavioral Rainbow tool
    The Rainbow tool visualizes perception based on lung function measurements and VAS scores.
  • Behavioral Feedback
    Feedback sessions with health care professional based on the Rainbow tool.

Primary outcome measures

  • Perception score [Time frame: Two week run-in versus last week of intervention]
Secondary outcome measures (6)
  • Perception score intervention groups [Time frame: Measured per week during the study period, which is 8 weeks]
  • Perception score over time [Time frame: Measured per week during the study period, which is 8 weeks]
  • Perception score zones [Time frame: Measured per week during the study period, which is 8 weeks]
  • Additional symptoms [Time frame: Measured per week during the study period, which is 8 weeks]
  • Drop-out rate [Time frame: Per study phase, 2 weeks for selection phase, 3 weeks for intervention phase and 3 weeks for follow-up phase]
  • User experience [Time frame: After the intervention phase, that takes 3 weeks]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Netherlands · 1 center
  • Medisch Spectrum Twente — Enschede

Identifiers

NCT: NCT06702735 · RAINBOW study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗