The Effect of Allergic Rhinitis on Educational Outcomes

Sponsor
ALK-Abelló A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05881577
Collaborator
Ernst & Young (Other)
150,000
1
5.5
27503.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Observational

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 [Patient Registry]
Anticipated Enrollment :
150000 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official Title:
The Effect of Allergic Rhinitis on Educational Outcomes - a Register-based Study
Actual Study Start Date :
Feb 15, 2023
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Cases

The primary study population will consist of subjects with AR

Other: Observational
Impact of AR on educational outcomes

Matched controls

children with no history of AR

Sibling controls

siblings of the subjects in the case group with no history of AR

Outcome Measures

Primary Outcome Measures

  1. Primary school final examination test grades (oral and written) in: Language (Danish, English), Mathematics Obtained high school degree Obtained university degree [1994-2021]

    Test grades

Secondary Outcome Measures

  1. Cost of inpatient and outpatient hospitalisation [1994-2021]

    Cost in DKK

  2. Cost of prescription medicine [1994-2021]

    Cost in DKK

  3. Number of inpatient and outpatient visits [1994-2021]

    The number of inpatient/outpatients visits per year.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 12 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • The main study population (cases) consists of children who have been diagnosed with AR before turning 13. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 ALK Abello Hørsholm Hovedstaden Denmark 2970

Sponsors and Collaborators

  • ALK-Abelló A/S
  • Ernst & Young

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT05881577
Other Study ID Numbers:
  • NI-X-06
First Posted:
May 31, 2023
Last Update Posted:
May 31, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2023