Asthma in ChildrenNCT06702735
The Rainbow Study - the Effect of Feedback on Asthmatic Symptom Perception
A study testing Rainbow tool and Feedback in people with Asthma in Children and Exercise Induced Asthma, run by Medisch Spectrum Twente at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Asthma in Children, Exercise Induced Asthma
- What is being tested?
- Rainbow tool and Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Oct 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 14Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Medisch Spectrum Twente
Enschede, Overijssel, 7512 KZ
Vera Hengeveld, MD, +316534872310, vera.hengeveld@mst.nl
Mattienne van der Kamp, MSc, +316534872310, m.vanderkamp@mst.nl
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma in Children, Exercise Induced Asthma
- Being tested
- Rainbow tool, Feedback
- Medical subject headings
- Asthma, Exercise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rainbow toolBehavioural
The Rainbow tool visualizes perception based on lung function measurements and VAS scores.
FeedbackBehavioural
Feedback sessions with health care professional based on the Rainbow tool.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Rainbow tool |
| Control group | No intervention | Collection of VAS scores and lung function. No additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Two week run-in versus last week of intervention
Secondary outcomes (6)
Perception score intervention groups
Difference between average perception score of intervention group (with feedback) and intervention (without feedback) group per week
Measured: 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: 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: 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: 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
Measured: 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
Measured: After the intervention phase, that takes 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start16 Oct 2023
- Primary completion1 Feb 2024
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vera Hengeveld, MD, Principal investigator, Medisch Spectrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702735
- Sponsor's protocol ID
- RAINBOW study
- Status last verified
- Nov 2024
- First submitted
- 16 Oct 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rainbow Study - a Randomized Controlled Trial to Evaluate the Effect of Personalized Feedback on Symptom Perception in Asthmatic Children
- ClinicalTrials.gov ID
- NCT06702735
- Acronym / sponsor ID
- RAINBOW study
- Conditions
- Asthma in Children, Exercise Induced Asthma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group (with feedback) | Experimental | Behavioral: Rainbow tool, Behavioral: FeedbackCollection 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 | Behavioral: Rainbow toolCollection 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. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Pediatrician diagnosed asthma
- Health care professional thinks perception might be poor
- Age 7 until 15 years old
- Adequate understanding of Dutch language
- Adequate number of lung function measurements + VAS scores during selection phase, defined as:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rainbow toolThe Rainbow tool visualizes perception based on lung function measurements and VAS scores. | Behavioural | Intervention group (with feedback), Intervention group (without feedback) |
| FeedbackFeedback sessions with health care professional based on the Rainbow tool. | Behavioural | Intervention group (with feedback) |
Primary outcome
Perception score
Time frame: Two week run-in versus last week of intervention
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
6 secondary outcomes
Perception score intervention groups
Time frame: Measured per week during the study period, which is 8 weeks
Perception score over time
Time frame: Measured per week during the study period, which is 8 weeks
Perception score zones
Time frame: Measured per week during the study period, which is 8 weeks
Additional symptoms
Time frame: Measured per week during the study period, which is 8 weeks
Drop-out rate
Time frame: Per study phase, 2 weeks for selection phase, 3 weeks for intervention phase and 3 weeks for follow-up phase
User experience
Time frame: After the intervention phase, that takes 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vera Hengeveld, MD principal investigator
Medisch Spectrum Twente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rainbow tool and Feedback in people with Asthma in Children and Exercise Induced Asthma, run by Medisch Spectrum Twente at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vera Hengeveld, MD (+31534872310, vera.hengeveld@mst.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception score (time frame: Two week run-in versus last week of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.