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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group (with feedback) | Experimental | 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. |
|
| Intervention group (without feedback) | Experimental | Collection of VAS scores and lung function. Explanation about the Rainbow tool to visualize symptom perception, and use of this tool during intervention phase. |
|
| Control group | No Intervention | Collection of VAS scores and lung function. No additional intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rainbow tool | Behavioral | The Rainbow tool visualizes perception based on lung function measurements and VAS scores. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Two week run-in versus last week of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Perception score intervention groups | Difference between average perception score of intervention group (with feedback) and intervention (without feedback) group per week | Measured per week during the study period, which is 8 weeks |
| Perception score over time |
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Inclusion Criteria:
Selection phase:
Intervention phase:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vera Hengeveld, MD | Contact | +31534872310 | vera.hengeveld@mst.nl | |
| Mattienne van der Kamp, MSc, PhD | Contact | +31534872310 | m.vanderkamp@mst.nl |
| Name | Affiliation | Role |
|---|---|---|
| Vera Hengeveld, MD | Medisch Spectrum Twente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medisch Spectrum Twente | Recruiting | Enschede | Overijssel | 7512 KZ | Netherlands |
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| ID | Term |
|---|---|
| D001250 | Asthma, Exercise-Induced |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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This study is a prospective, non-blinded randomized controlled trial with three parallel arms. After a selection phase of 2 weeks, eligible participants were equally allocated to the study arms (ratio 1:1:1). The intervention phase consists of three weeks, followed by a follow-up of two weeks.
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| Feedback | Behavioral | Feedback sessions with health care professional based on the Rainbow tool. |
|
Perception scores (0-100) and average perception score per week. Including over- or underperception |
| 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 | 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 | 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 | 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 | After the intervention phase, that takes 3 weeks |
| D000092202 |
| Exercise-Induced Allergies |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |