Allergic Rhinitis Improvement Through Strategic Education: The ARISE Trial

NCT06686446 | Terminated

• 1 other identifier: NACE-003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergy

Keywords

Allergy Rhinitis

Outcome Measures

Primary Outcomes (1)

• Difference between the two treatment arms (experimental versus standard of care) in participant nasal symptomatology: Change in total scores 6 weeks post commencement of INCS or INAH+INCS

  Patient reported nasal symptomatology scores completed using the validated Total Nasal Symptom Score (TNSS) questionnaire. The TNSS questionnaire is a validated questionnaire to assess nasal symptomatology and consists of 3 questions. Total scores are calculated by adding the sum of completed items. Questions are based on a 3 point Likert scale, with scores of 6 or more indicating moderate to severe allergic rhinitis.

  Baseline and 6-weeks post-randomisation

Secondary Outcomes (6)

• Difference between treatment arms in participant nasal symptomatology: Change in total scores 9 months post commencement of INCS or INAH+INCS

  Baseline and 9-months post-randomisation

• Change between treatment arms in participant ocular symptomatology

  Baseline, 6 weeks post randomisation and 9 months post randomisation

• Mean change between treatment arms in Quality of Life Scores using the Rhinitis Control Assessment Test (RCAT)

  Baseline, 6 weeks post randomisation, 9 months post randomisation

• Change between treatment arms in participant knowledge, attitude and practice on nasal steroid and its uses

  Baseline, 6 weeks post randomisation and 9 months post randomisation

• Change between treatment arms in total scores for participant INCS or INCS+INAH application technique

  Baseline, 6 weeks and 9 months post randomisation

Other Outcomes (1)

• Exploratory objective: Effect of factors influencing the effectiveness of the Enhanced Education Package: A percentage total is assigned to the factors studied

  Baseline and 6 weeks post randomisation

Study Arms (2)

Enhanced Education Package

EXPERIMENTAL

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

Behavioral: Enhanced Education Package

Standard of care

NO INTERVENTION

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.

Interventions

Enhanced Education Package BEHAVIORAL

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. 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.

Enhanced Education Package

Eligibility Criteria

• Age: 14 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

Study Sites (1)

Murdoch Children's Research Institute

Parkville, Victoria, 3052, Australia

Location

Related Links

• ARISE trial information

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Kirsten M Perrett, MBBS, FRACP, PhD

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, interventional, randomised trial, evaluating the impact and effectiveness of a new AR education package used in conjunction with daily INCS or INCS+INAH treatment to reduce AR-related symptomatology and improve quality of life, in comparison to the standard of care education that is currently provided. A decentralized clinical trial model will be used to facilitate and augment the recruitment of participants across different geographical locations around Australia to align with the seasonal pollen changes in various states and territories. Consented participants will be randomised 1:1 to either the intervention group who receive an Enhanced Education Package (EEP) which is a targeted set of patient education tools and weekly email/SMS reminders over a 6 week period, or to the control group (standard of care), which may include management by a general practitioner, specialist, pharmacist, or self-management).

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 13, 2024
• Study Start: August 22, 2025
• Primary Completion: February 5, 2026
• Study Completion: February 5, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE
• Time Frame: On completion of the ARISE study, de-identified data, encrypted with NACE unique identifier codes and secure linkage key tokens, will be transferred to the ALBI platform, for storage, integration and sharing for future HREC-approved allergy research purposes. Data once in ALBI remains indefinitely.
• Access Criteria: ALBI will only provide researchers with non-identifiable information related to the specific project, following the Scientific Access Framework. Researchers need to apply for access to ALBI data. This is done via NACE email: nace@mcri.edu.au. Once approved, data will be made available to the researchers by logging in through a secure research platform. Researchers will not have access to the entire ALBI system as they will be provided extracts from ALBI of non-identifiable information related to their specific project upon request and approvals. Information will only be shared with ethically approved future allergy research studies. For more information about the data deidentification process.

Locations

AU (1)