The Effect of Allergic Rhinitis on Educational Outcomes

NCT05881577 | Unknown

• 1 other identifier: NI-X-06
• Study Type: observational
• Target: 150,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Primary school final examination test grades (oral and written) in: Language (Danish, English), Mathematics Obtained high school degree Obtained university degree

  Test grades

  1994-2021

Secondary Outcomes (3)

• Cost of inpatient and outpatient hospitalisation

  1994-2021

• Cost of prescription medicine

  1994-2021

• Number of inpatient and outpatient visits

  1994-2021

Study Arms (3)

Cases

The primary study population will consist of subjects with AR

Other: Observational

Matched controls

children with no history of AR

Sibling controls

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

Interventions

Observational OTHER

Impact of AR on educational outcomes

Cases

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

children who have been diagnosed with AR before turning 13

You may qualify if:

• 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).

You may not qualify if:

• Children with their first AR-related healthcare contact or first AR-specific dispensed prescription at the age of 13 or older will be excluded.

Sponsors & Collaborators

• ALK-Abelló A/S: lead
• Ernst & Young: collaborator

Study Sites (1)

ALK Abello

Hørsholm, Capital Region, 2970, Denmark

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Mercedes Romano, Pharm D, MBA

CONTACT

+4522971265; MRRDK@ALK.NET

Mikkel H Pedersen

CONTACT

+4560177416; Mikkel.H.Pedersen@dk.ey.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 25 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: May 31, 2023
• Study Start: February 15, 2023
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

DK (1)