Allergic Rhinitis Improvement Through Strategic Education: The ARISE Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Allergic Rhinitis, or hay fever, is a common allergic chronic condition that affects many Australians, with its prevalence rates increasing each year due to environmental factors and affects all age groups. Evidence shows a large proportion of individuals with hay fever, whether it is seasonal, perennial (all year round) or occupational, will not seek medical help and instead rely on over the counter medications. This often leads to inadequate treatment and poor control of symptoms, impacting their quality of life, symptom burnout and economic burden. There are effective treatments available including Intranasal Corticosteroid (INCS) sprays or combination INCS + Intranasal Antihistamine (INAH) sprays, but they need to be used correctly and as directed for best results. Previous studies have shown that many adults and children who use INCS+INAH do not know the right way to use them because they are not provided with enough education and awareness. Studies also show that adolescents and young adults are more likely to not follow their treatment plan because they worry about minor side effects INCS or INCS+INAH can cause, and misconceptions that can come from a lack of education. However, these concerns can be avoided if they are guided and educated on the correct techniques, knowledge through repeat education.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 29
Healthy Volunteers: f
View:

• Adolescents and young adults aged 14-29 years experiencing moderate to severe AR symptoms (defined by ARIA guidelines if AR symptoms significantly affect sleep or activities of daily living, and/or if they are considered bothersome (15)) and is using or commencing INCS or combination INCS+INAH treatment.

• A previous positive SPT and/or sIgE to at least one aeroallergen

• Ability to understand and comply with study requirements and provide informed consent

Locations
Other Locations
Australia
Murdoch Children's Research Institute
RECRUITING
Parkville
Contact Information
Primary
National Allergy Centre of Excellence
nace@mcri.edu.au
61 3 99366752
Time Frame
Start Date: 2025-08-22
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 194
Treatments
Experimental: Enhanced Education Package
Participants randomised to the intervention arm will receive an advanced patient education toolkit and reminders delivered by email/SMS in addition to the standard education which may include management by a general practitioner, specialist, pharmacist, or self-management.~The EEP will contain:~* Dosing/frequency - links for package inserts for INCS and INCS+INAH~* Correct INCS or INCS+INAH technique - the study team will ask participants to show them the correct technique in taking their nasal spray~* Weekly repeat reminders - these reminders will be sent via either SMS or email over a period of 6 weeks. They will instruct and remind the participant to take their INCS or INCS+INAH as per their treating clinician recommendation and why it is important to take it as instructed.~* Education Toolkit - contains links to websites of key organisations which include educational videos and other resources
No_intervention: Standard of care
Participants randomised to the control arm will receive standard of care education, which may include management by a general practitioner, specialist, pharmacist, or self-management.~After randomisation, the study team will confirm what education the participants have received and that they can display the correct technique in taking their nasal spray. The research assistant/study nurse can re-educate the participant until the correct technique is displayed.
Related Therapeutic Areas
Sponsors
Leads: Murdoch Childrens Research Institute

This content was sourced from clinicaltrials.gov