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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53605
Enrollment
45
Registered
2023-06-12
Start date
2023-10-16
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma inflammation of small airways

Interventions

Maesuring lung function and symptoms and using the Rainbow tool to assess perception. In the intervention group + feedback there is a weekly online session to discuss the performed measurements and

Sponsors

Medisch Spectrum Twente
Lead Sponsor

Eligibility

Age
2 Years to 15 Years

Inclusion criteria

Inclusion criteria: Selection phase: - Pediatrician diagnosed asthma - Health care profesionnal thinks perception might be poor - Age 7 until 15 years old - Adequate understanding of Dutch language Intevention 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 measrurements in yellow zone (or orange/red)

Exclusion criteria

Exclusion criteria: -Severe comorbidity (for example psychomotor retardation or severe cardiopulmonary conditions) -Not able to fill in VAS score (for example due to blindless) -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

Design outcomes

Primary

MeasureTime frame
The diference in average perception score during the last week of the run-in and the last week of the intevention between the intervention+feedback and control group The following calculation is used to calculate the perception score: Perception score = 100 - ((FEV1-(100- VAS*-7))/10)^ 2

Secondary

MeasureTime frame
-Difference between average perception score of intervention group and intervention+ feedback group in the different weeks -Perception score and average perceptionscore per week -Number of perception scores in green/yellow/red zone (absolute and relative) per week -Over- or underperception score (ABS((FEV1-(100-VAS*7)))/((FEV1-(100-VAS*7))))*((FEV1-(100-VAS*7))/10)^2. A negative score reflects underperception and a positive score reflects overperception -Type of symptom when measurement (lung function + VAS) was performed -Number of approached patients and reasons for not participating -Number of patients that drop-out during or after selection phase and reasons for drop-out -User experiencences based on semi-structured interview and quetionnaire 1 (see apendix) -User experiences based on drop-outs and number + type of lung function measurments per week

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)