An interventional study of Rainbow tool and Feedback in Asthma in Children and Exercise Induced Asthma, sponsored by Medisch Spectrum Twente. Recruiting at 1 site in Netherlands. Open to participants aged 7 Years to 15 Years. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Medisch Spectrum Twente · Not applicable, Interventional, and Diagnostic
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.
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.
52 studies on the registry are indexed under Asthma, Exercise-Induced; 3 are open to participants now.
This study's planned enrollment of 39 is below the median of 47 across 40 interventional studies indexed under Asthma, Exercise-Induced.
Browse Asthma, Exercise-Induced studies →Medisch Spectrum Twente is the lead sponsor of 23 studies on the registry; 10 are open to participants now.
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Selection phase:
Intervention phase:
Exclusion Criteria:
Collection of VAS scores and lung function. Explanation about the Rainbow tool to visualize symptom perception, and use of this tool during intervention phase. Feedback sessions with health care professional to evaluate symptom perception using the Rainbow tool.
Behavioral: Rainbow tool · Behavioral: Feedback
Collection of VAS scores and lung function. Explanation about the Rainbow tool to visualize symptom perception, and use of this tool during intervention phase.
Behavioral: Rainbow tool
Collection of VAS scores and lung function. No additional intervention.
The Rainbow tool visualizes perception based on lung function measurements and VAS scores.
Feedback sessions with health care professional based on the Rainbow tool.
Perception score
The difference in the average perception score (0-100) during the two-week run-in and last week of the intervention between the intervention group (with feedback) and the control group
Time frame: Two week run-in versus last week of intervention
Perception score intervention groups
Difference between average perception score of intervention group (with feedback) and intervention (without feedback) group per week
Time frame: Measured per week during the study period, which is 8 weeks
Perception score over time
Perception scores (0-100) and average perception score per week. Including over- or underperception
Time frame: Measured per week during the study period, which is 8 weeks
Perception score zones
Number of perception scores in green/yellow/red zone (absolute and relative) per week
Time frame: Measured per week during the study period, which is 8 weeks
Additional symptoms
Type of additional symptom when measurement (lung function + VAS) is performed: no additional symptoms, cough, wheezing, chest pain, feeling dizzy, nasal symptoms
Time frame: Measured per week during the study period, which is 8 weeks
Drop-out rate
Number of patients that drop-out during or after selection phase and reasons for drop-out
Time frame: Per study phase, 2 weeks for selection phase, 3 weeks for intervention phase and 3 weeks for follow-up phase
User experience
User experience based on semi-structured interview and user experience + technology acceptance questionnaire after the intervention phase
Time frame: After the intervention phase, that takes 3 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2023 to primary completion in Feb 2024, 3 months.
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