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Allergic Rhinitis Improvement through Strategic Education: The ARISE Trial

Impact and effectiveness of a new allergic rhinitis education package used in conjunction with daily combination nasal sprays in adolescents and young adults.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001217594
Enrollment
194
Registered
2024-10-04
Start date
2024-11-01
Completion date
2025-11-01
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to evaluate the impact and effectiveness of a new AR education package used in conjunction with daily INCS/INAH in reducing AR symptomatology and improving quality of life, in comparison to the standard of care education that is currently provided via treating healthcare professionals. Ultimately, it is hoped the results of this study will improve education management of those living with the burden of AR. This flows on to benefit families, carers, the healthcare system and the wider community.

Interventions

Participants will be recruited following standard consultations with their regular treating clinician and confirmation of moderate to severe allergic rhinitis diagnosis and a positive Skin Prick Test (SPT) to at least one environmental allergen. The treating clinician will provide patients with a recommendation/ prescription (if required) for Combination Intra-nasal corticosteroids and Intranasal antihistamine spray (INCS/INAH) and the minimum standard of care education including demonstration

Participants will be recruited following standard consultations with their regular treating clinician and confirmation of moderate to severe allergic rhinitis diagnosis and a positive Skin Prick Test (SPT) to at least one environmental allergen. The treating clinician will provide patients with a recommendation/ prescription (if required) for Combination Intra-nasal corticosteroids and Intranasal antihistamine spray (INCS/INAH) and the minimum standard of care education including demonstration of correct INCS/INAH application technique and a personalised Australasian Society of Clinical Immunology and Allergy (ASCIA) Allergic Rhinitis (AR) Treatment Plan. Post confirmation of AR diagnosis, the treating clinician will inform their patient about the study. If patients are interested in participating or wish to know more, they can register their expression of interest (EOI) via an online webform accessed via a QR code located on the flyer they are given by their treating clinician. Following submission of an EOI form an SMS message will be sent to the participant, providing them with a bookings link so they can select their preferred time of the video telehealth call. with a study team member. In addition, a copy of the Participant Information Consent Form (PICF) will be automatically sent to their nominated email address to allow time for them to read and discuss the study with friends and family. The first telehealth call will be conducted within 3-4 working days after registering to discuss the study, answer any questions, obtain informed consent and complete the enrollment visit. An individual can reschedule their telehealth call if the day and time is not suitable. 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 provided by their treating clinician. After randomisation, the study team will confirm participants received the standard of care education resources at their consult visit with their treating clinician. The study team will re-educate and discuss these educational resources with them. If randomised to the Enhanced Education Package (EEP), the study team will educate on the additional resources and how the repeat reminders will work. Both groups are reminded to continue to see their treating clinician and to attend any appointments they may have. The EEP group will be educated by the study team that will take approximately 30 mins and will contain: • Dosing/frequency – links for the package inserts for Dymista/Ryaltris will be provided and the study team will re-educate participants about the importance of following the dosage and frequency as prescribed by the treating clinician. • INCS/INAH technique – the study team will ask participants to show them the correct technique in taking their nasal spray and provide a link to the ASCIA guidelines for INCS/INAH application. The study team can re-educate the participant until the correct technique is displayed. • ASCIA AR Treatment Plan – the study team will check each participant has been provided with a plan by their treating clinician and go through the plan. If the participant does not understand their plan or needs further information on dosage and frequency, the study team will ask the participant to contact their treating clinician to organise an appointment to be reviewed. The study team will also send a letter to the treating clinician explaining this. • Weekly repeat reminders – these reminders will be sent via either SMS or email over a period of 3 months. They will instruct and remind the participant to take their 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 including the National Allergy Council (NAC), Allergy & Anaphylaxis Australia (A&AA), Australasian Society of Clinical Immunology and Allergy (ASCIA), National Asthma Council Australia (NACA) and AusPollen which include educational videos and other resources. Participants are not required to complete any education surveys from the education toolkit. The study is measuring the metrics regarding the use of the resources from the clicks and page views through the email distribution system we are using. There is no strategies used to assess adherence.

Sponsors

Murdoch Children's Research Institute
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
14 Years to 29 Years
Healthy volunteers
No

Inclusion criteria

1. Adolescents and young adults aged 14-29 years diagnosed by their treating clinician with moderate to severe AR (defined by ARIA guidelines if AR symptoms significantly affect sleep or activities of daily living, and/or if they are considered bothersome (15)) at a participating recruitment site by symptomatology and positive SPT to at least one aeroallergen and has been prescribed/recommended Dymista or Ryaltris 2. Ability to understand and comply with study requirements and provide informed consent

Exclusion criteria

1. Current or previous treatment for AR with aeroallergen immunotherapy (patients will be specifically asked if they have ever received subcutaneous immunotherapy (SCIT) or sublingual immunotherapy (SLIT) for aeroallergens such as pollen, house dust mite, cats, dogs and horses)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026