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

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma in Children; Exercise Induced Asthma
• Intervention / Treatment: Behavioral: Rainbow tool; Behavioral: Feedback

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.

• Study Type: Interventional
• Enrollment (Estimated): 39
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vera Hengeveld, MD; Phone Number: +31534872310; Email: vera.hengeveld@mst.nl
• Study Contact Backup: Name: Mattienne van der Kamp, MSc, PhD; Phone Number: +31534872310; Email: m.vanderkamp@mst.nl

Study Locations

• Netherlands
  • Overijssel
    • Enschede, Overijssel, Netherlands, 7512 KZ
      • Recruiting
      • Medisch Spectrum Twente
      • Contact: Vera Hengeveld, MD; Phone Number: +316534872310; Email: vera.hengeveld@mst.nl
      • Contact: Mattienne van der Kamp, MSc; Phone Number: +316534872310; Email: m.vanderkamp@mst.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group (with 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. Feedback sessions with health care professional to evaluate symptom perception using the Rainbow tool.	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.
Experimental: Intervention group (without 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; The Rainbow tool visualizes perception based on lung function measurements and VAS scores.
No Intervention: Control group; Collection of VAS scores and lung function. No additional intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Medisch Spectrum Twente
• Investigators: Principal Investigator: Vera Hengeveld, MD, Medisch Spectrum Twente

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Estimated): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Exercise-Induced Allergies; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Asthma, Exercise-Induced
• Other Study ID Numbers: RAINBOW study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No