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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 15
Healthy Volunteers: f
View:

⁃ 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)

Locations
Other Locations
Netherlands
Medisch Spectrum Twente
RECRUITING
Enschede
Contact Information
Primary
Vera Hengeveld, MD
vera.hengeveld@mst.nl
+31534872310
Backup
Mattienne van der Kamp, MSc, PhD
m.vanderkamp@mst.nl
+31534872310
Time Frame
Start Date: 2023-10-16
Estimated Completion Date: 2025-05-01
Participants
Target number of participants: 39
Treatments
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.
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.
No_intervention: Control group
Collection of VAS scores and lung function. No additional intervention.
Related Therapeutic Areas
Sponsors
Leads: Medisch Spectrum Twente

This content was sourced from clinicaltrials.gov