The Rainbow Study - the Effect of Feedback on Asthmatic Symptom Perception
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-15
SponsorMedisch Spectrum Twente
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatrician diagnosed asthma
Health care professional thinks perception might be poor
Age 7 until 15 years old
Adequate understanding of Dutch language
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Rainbow tool
BehavioralThe Rainbow tool visualizes perception based on lung function measurements and VAS scores.
Feedback
BehavioralFeedback sessions with health care professional based on the Rainbow tool.
Treatment groups
39 Participants
are divided into 3 treatment groupsGroup A: Intervention group (with feedback)Experimental treatment 2 interventions
Group B: Intervention group (without feedback)Experimental treatment 1 intervention
Group C: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 interventionSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
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Source ClinicalTrials.gov