Clinical trial NCT06686446: Allergic Rhinitis Improvement Through Strategic Education: The ARISE Trial
Official title: Allergic Rhinitis Improvement Through Strategic Education: The ARISE Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Allergy
Keywords: Allergy Rhinitis
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 194
Sex: ALL
Minimum age (years): 14
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, interventional, randomised trial, evaluating the impact and effectiveness of a new AR education package used in conjunction with daily 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.

Participants will be randomised 1:1 to receive either the Enhanced Education Package (EEP) or continue with the standard of care education that they receive from their treating clinician. The EEP includes an advanced patient education toolkit and reminders delivered by email/SMS.
Primary purpose: TREATMENT

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 antihistamines (INAH), intranasal corticosteroids (INCS) or combination INCS/INAH, 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/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.

This study aims to evaluate the impact and effectiveness of a new Allergic Rhinitis (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.

Detailed description: 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.

Patients aged 14-29 years old will be recruited following initial standard consultations and confirmation of moderate to severe AR diagnosis (defined by Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines if AR symptoms significantly affect sleep or activities of daily living, and/or if they are considered bothersome) and a positive skin prick test for one or more aeroallergens. The treating clinician will provide patients with a recommendation/ prescription (if required) for INCS/INAH and the minimum standard of care education containing information on dosing instructions/correct INCS/INAH application technique and a personalised ASCIA AR Treatment Plan. The treating clinician will inform their potentially eligible patients about the study and provide them with recruitment aids in the form of an A5 study flyer to register their interest and receive more information. If patients wish to know more about the study, they will be able to register their interest via an online form. The primary site study team will contact the patient after receiving their expression of interest via a telehealth video call to discuss the study and answer any questions. If the patient is deemed eligible, informed consent will be completed via an eConsent process.

Participants will be randomised 1:1 to receive either the Enhanced Education Package (EEP) or continue with the standard of care education that they receive from their treating clinician. The EEP includes an advanced patient education toolkit and reminders delivered by email/SMS

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. Participants randomised to the intervention arm (Enhanced Education Package) will receive an advanced patient education toolkit and reminders delivered by email/SMS in addition to the standard education provided by their treating clinician. Participants randomised to the control arm will receive the basic standard of care education delivered by their treating clinician. Both groups are reminded to continue to see their treating clinician and to attend any appointments they may have.

Eligibility criteria: 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)

Primary outcomes:
measure: Difference between the two treatment arms (experimental versus standard of care) in participant nasal symptomatology: Change in total scores 3 months post commencement of INAH/INCS
timeFrame: Baseline and 3-months post-randomisation
Secondary outcomes:
measure: Difference between treatment arms in participant nasal symptomatology: Change in total scores 9 months post commencement of INAH/INCS
timeFrame: Baseline and 9-months post-randomisation
measure: Change between treatment arms in participant ocular symptomatology
timeFrame: Baseline, 3-months post randomisation and 9-months post randomisation
measure: Mean change between treatment arms in Quality of Life Scores using the Rhinitis Control Assessment Test (RCAT)
timeFrame: Baseline, 3 months post randomisation, 9 months post randomisation
measure: Change between treatment arms in participant knowledge, attitude and practice on nasal steroid and its uses
timeFrame: Baseline, 3 months and 9 months post randomisation
measure: Change between treatment arms in total scores for participant INCS/INAH application technique
timeFrame: Baseline, 3-months and 9-months post-randomisation
measure: Change between treatment arms in participant engagement with educational resources from baseline to 3 months
timeFrame: Baseline then at 1 month, 2 months, 3 months
Other outcomes:
measure: Exploratory objective: Effect of factors influencing the effectiveness of the Enhanced Education Package: A percentage total is assigned to the factors studied
timeFrame: Baseline and 3 month post randomisation
Locations:
city: Parkville
country: Australia
facility: Murdoch Children's Research Institute
state: Victoria
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Kirsten M Perrett, MBBS, FRACP, PhD
role: PRINCIPAL_INVESTIGATOR
References: