The Rainbow Study - the Effect of Feedback on Asthmatic Symptom Perception

NCT06702735 | Recruiting

• 1 other identifier: RAINBOW study
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma in Children; Exercise Induced Asthma

Outcome Measures

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

  Two week run-in versus last week of intervention

Secondary Outcomes (6)

• Perception score intervention groups

  Measured per week during the study period, which is 8 weeks

• Perception score over time

  Measured per week during the study period, which is 8 weeks

• Perception score zones

  Measured per week during the study period, which is 8 weeks

• Additional symptoms

  Measured per week during the study period, which is 8 weeks

• Drop-out rate

  Per study phase, 2 weeks for selection phase, 3 weeks for intervention phase and 3 weeks for follow-up phase

Study Arms (3)

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.

Behavioral: Rainbow tool; Behavioral: Feedback

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.

Behavioral: Rainbow tool

Control group

NO INTERVENTION

Collection of VAS scores and lung function. No additional intervention.

Interventions

Rainbow tool BEHAVIORAL

The Rainbow tool visualizes perception based on lung function measurements and VAS scores.

Intervention group (with feedback); Intervention group (without feedback)

Feedback BEHAVIORAL

Feedback sessions with health care professional based on the Rainbow tool.

Intervention group (with feedback)

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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
• No device (computer, tablet or smartphone) with internet connection available at home

Sponsors & Collaborators

• Medisch Spectrum Twente: lead

Study Sites (1)

Medisch Spectrum Twente

Enschede, Overijssel, 7512 KZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Asthma, Exercise-Induced

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Vera Hengeveld, MD

  Medisch Spectrum Twente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vera Hengeveld, MD

CONTACT

+31534872310; vera.hengeveld@mst.nl

Mattienne van der Kamp, MSc, PhD

CONTACT

+31534872310; m.vanderkamp@mst.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 25, 2024
• Study Start: October 16, 2023
• Primary Completion: February 1, 2024
• Study Completion: May 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)