Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001217594p
Ethics application status
Submitted, not yet approved
Date submitted
18/09/2024
Date registered
4/10/2024
Date last updated
4/10/2024
Date data sharing statement initially provided
4/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Allergic Rhinitis Improvement through Strategic Education: The ARISE Trial
Scientific title
Impact and effectiveness of a new allergic rhinitis education package used in conjunction with daily combination nasal sprays in adolescents and young adults.
Secondary ID [1] 312942 0
NACE-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Rhinitis 335110 0
Condition category
Condition code
Inflammatory and Immune System 331614 331614 0 0
Allergies
Respiratory 331615 331615 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 329481 0
Behaviour
Intervention code [2] 329597 0
Treatment: Other
Comparator / control treatment
Participants randomised to the control arm will receive the basic standard of care education delivered by their treating clinician. After randomisation, the study team will confirm participants received:

• Correct INCS/INAH technique – the study team will ask participants to show them the correct technique in taking their nasal spray. The nurses 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, study nurses/research assistants 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.
Control group
Active

Outcomes
Primary outcome [1] 339358 0
To assess the short-term efficacy of the EEP vs standard education on nasal symptomatology
Timepoint [1] 339358 0
Baseline and 3-months post-randomisation
Secondary outcome [1] 439635 0
To assess the long-term efficacy of the EEP vs standard education on AR nasal symptomatology
Timepoint [1] 439635 0
Baseline and 9 months post-randomisation
Secondary outcome [2] 439636 0
To assess the efficacy of EEP vs standard education on ocular symptomatology
Timepoint [2] 439636 0
Baseline, 3 months and 9 months post randomisation
Secondary outcome [3] 439637 0
To assess the efficacy of the EEP vs standard education on quality of life
Timepoint [3] 439637 0
Baseline, 3 months and 9 months post randomisation.
Secondary outcome [4] 439640 0
To assess INCS/INAH application technique in participants receiving the EEP vs standard education
Timepoint [4] 439640 0
Baseline, 3 months and 9 months post randomisation
Secondary outcome [5] 439641 0
To assess levels of engagement with the EEP
Timepoint [5] 439641 0
During the 3 month intervention period
Secondary outcome [6] 439642 0
Exploratory Outcome: To assess factors influencing the effectiveness of the EEP
Timepoint [6] 439642 0
Baseline and 3 months post randomisation

Eligibility
Key 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
Minimum age
14 Years
Maximum age
29 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be completed by a database (computer). The study team will not have access or be able to view the randomisation schedule until a participant has been randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Study participants will be randomly assigned, in a 1:1 ratio to receive either the EEP or standard of care education. A statistician not directly involved in the analysis of the trial results will prepare the randomisation schedule using block randomisation to maintain balance between treatment arms. Randomisation will be stratified by participant state/territory of residence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome of TNSS will be analysed using linear regression adjusted for prespecified baseline covariates (e.g. baseline TNSS, aeroallergen sensitisation profile) and stratification variable state/territory of residence. This model will be used to calculate the difference in means between the two randomised treatment arms, with a 95% confidence interval at 3- and 9-months post randomisation.

The continuous secondary outcomes (EAPIQ, RQLQ/AdolRQLQ, KAP, INCS/INAH application technique), will be analysed using linear regression adjusted for prespecified baseline covariates (e.g baseline TNSS, aeroallergen sensitisation profile) and stratification variable state/territory of residence. This model will be used to calculate the difference in means between the two randomised treatment arms, with a 95% confidence interval at 3 and 9-months post randomisation.

We reason that since the size of the increment in the number of steps on the INCS/INAH application technique score is constant, it is appropriate to analyse this outcome with linear regression, even though the outcome is not a continuous variable. The mean number of times (with 95% confidence interval) each participant engaged with the EEP will be provided in the intervention arm only.

To assess whether the following factors influence the effectiveness of the intervention, we will fit a linear regression, as for the primary outcome, also including the interaction between the factor and the treatment arm. If the interaction effect is statistically significant, we would conclude that the factor influences the effectiveness of the intervention. These factors are: baseline AR severity (TNSS score at baseline), type of AR (seasonal or perennial), age, baseline KAP, demographic variable rurality (urban vs rural and remote), ethnicity, language (speaks English at home vs do not speak English at home), sensitisation and allergy history, on TNSS at 3- and 9-months. This analysis is explorative in nature and would not be able to provide any definitive conclusion, since the study is not powered to answer this question.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
1/11/2025
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
194
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317377 0
Government body
Name [1] 317377 0
Commonwealth Government
Country [1] 317377 0
Australia
Primary sponsor type
Other
Name
Murdoch Children's Research Institute
Address
Country
Australia
Secondary sponsor category [1] 319666 0
Other
Name [1] 319666 0
National Allergy Centre of Excellence
Address [1] 319666 0
Country [1] 319666 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316106 0
The Royal Children’s Hospital Human Research Ethics Committee
Ethics committee address [1] 316106 0
Ethics committee country [1] 316106 0
Australia
Date submitted for ethics approval [1] 316106 0
13/08/2024
Approval date [1] 316106 0
Ethics approval number [1] 316106 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136802 0
Prof Connie Katelaris
Address 136802 0
50 Flemington Road, Parkville VIC 3052
Country 136802 0
Australia
Phone 136802 0
+61 9936 6752
Fax 136802 0
Email 136802 0
nace@mcri.edu.au
Contact person for public queries
Name 136803 0
National Allergy Centre of Excellence
Address 136803 0
50 Flemington Road, Flemington VIC 3052
Country 136803 0
Australia
Phone 136803 0
+61 9936 6752
Fax 136803 0
Email 136803 0
nace@mcri.edu.au
Contact person for scientific queries
Name 136804 0
National Allergy Centre of Excellence
Address 136804 0
50 Flemington Road, Flemington VIC 3052
Country 136804 0
Australia
Phone 136804 0
+61 9936 6752
Fax 136804 0
Email 136804 0
nace@mcri.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified study data will be transferred to the NACE Allergy BioRepository (ALBI) for secondary future research.
When will data be available (start and end dates)?
At the completion of the study, de-identified data will be transferred to the NACE Allergy BioRepository (ALBI) for secondary future research. Data to be transferred is estimated to occur 31st October 2026. Once the data is in ALBI, there is no end date.
Available to whom?
NACE Allergy BioRepository (ALBI) will provide allergy and immunology researchers with non-identifiable information related to the specific project, following the Scientific Access Framework.
Available for what types of analyses?
The ALBI platform serves as an organized secure data transfer, integration and storage platform for research information collected to be shared with allergy researchers for future approved allergy and immunology studies according to agreed data management, governance and Scientific Access Committee processes. Data will be in a non-identifiable format.
How or where can data be obtained?
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 to access the non-identifiable information related to their specific project upon request and approvals. They will not have access to the entire ALBI system.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.