The Effect of Allergic Rhinitis on Educational Outcomes

May 26, 2023 updated by: ALK-Abelló A/S

The Effect of Allergic Rhinitis on Educational Outcomes - a Register-based Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

150000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mercedes Romano, Pharm D, MBA
  • Phone Number: +4522971265
  • Email: MRRDK@ALK.NET

Study Contact Backup

Study Locations

  • Denmark
    • Hovedstaden
      • Hørsholm, Hovedstaden, Denmark, 2970
        • Recruiting
        • ALK Abello
        • Contact:
          • Mercedes Romano, PharmD MBA
          • Phone Number: +4522971265
          • Email: MRRDK@ALK.NET

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

children who have been diagnosed with AR before turning 13

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1994-2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost of inpatient and outpatient hospitalisation
Time Frame: 1994-2021
Cost in DKK
1994-2021
Cost of prescription medicine
Time Frame: 1994-2021
Cost in DKK
1994-2021
Number of inpatient and outpatient visits
Time Frame: 1994-2021
The number of inpatient/outpatients visits per year.
1994-2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ALK-Abelló A/S

Collaborators

Ernst & Young

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Estimated)

July 31, 2023

Study Completion (Estimated)

July 31, 2023

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI-X-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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