The Effect of Allergic Rhinitis on Educational Outcomes - a Register-based Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- ALK-Abelló A/S
- Enrollment
- 150,000
- Locations
- 1
- Primary Endpoint
- Primary school final examination test grades (oral and written) in: Language (Danish, English), Mathematics Obtained high school degree Obtained university degree
Study Overview
Brief Summary
The study will assess the the burden of living with allergic rhinitis (AR) and the effect of AR on school performance for children and adolescents in Denmark.
Detailed Description
The aim of the study is to investigate the effect of AR on school performance and examination test grades for children and adolescents diagnosed with AR early in life, as well as analyse their burden of disease and healthcare resource use using real-world data from the exhaustive Danish population registers. This is a retrospective registry analysis that uses Danish registers during 1994 and 2021.
In Denmark, national registers collect data for the entire Danish population from birth to death and have done so for decades. This exhaustive data creates a sound foundation for this study of the impact of school performance caused by AR, as subjects can be traced with high certainty and detail over several years.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 5 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The main study population (cases) consists of children who have been diagnosed with AR before turning
- •Diagnosis of AR will be identified by dispensations of prescribed AR medications, ICD-10 codes of AR-related hospitalisations and reimbursement codes for AR-related healthcare contacts in the primary healthcare sector.
- •At least two dispensed prescriptions of product containing intranasal corticosteroids (INCS) or antihistamines during the same calendar year for two consecutive years OR at least one visit with the primary healthcare sector with registered AR consultations AND at least one dispensed prescriptions of product containing INCS or antihistamines OR at least one contact with the hospital sector with an ICD-10 code for AR (primary or secondary diagnosis).
Exclusion Criteria
- •Children with their first AR-related healthcare contact or first AR-specific dispensed prescription at the age of 13 or older will be excluded.
Outcomes
Primary Outcomes
Primary school final examination test grades (oral and written) in: Language (Danish, English), Mathematics Obtained high school degree Obtained university degree
Time Frame: 1994-2021
Test grades
Secondary Outcomes
- Cost of prescription medicine(1994-2021)
- Cost of inpatient and outpatient hospitalisation(1994-2021)
- Number of inpatient and outpatient visits(1994-2021)