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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06686446




Registration number
NCT06686446
Ethics application status
Date submitted
11/11/2024
Date registered
13/11/2024

Titles & IDs
Public title
Allergic Rhinitis Improvement Through Strategic Education: The ARISE Trial
Scientific title
Allergic Rhinitis Improvement Through Strategic Education: The ARISE Trial
Secondary ID [1] 0 0
NACE-003
Universal Trial Number (UTN)
Trial acronym
ARISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergy 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Enhanced Education Package

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 provided by their treating clinician.

The EEP will contain:

* Dosing/frequency - links for package inserts for Dymista / Ryaltris (olopatadine-mometasone)
* Correct INCS/INAH technique - the study team will ask participants to show them the correct technique in taking their nasal spray
* ASCIA AR Treatment Plan - the study team will check each participant has been provided with a plan 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 which include educational videos and other resources

No intervention: Standard of care - 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.
* ASCIA AR Treatment Plan - the study team will check each participant has been provided with a plan by their treating clinician. 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.


BEHAVIORAL: 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 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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline and 3-months post-randomisation
Secondary outcome [1] 0 0
Difference between treatment arms in participant nasal symptomatology: Change in total scores 9 months post commencement of INAH/INCS
Timepoint [1] 0 0
Baseline and 9-months post-randomisation
Secondary outcome [2] 0 0
Change between treatment arms in participant ocular symptomatology
Timepoint [2] 0 0
Baseline, 3-months post randomisation and 9-months post randomisation
Secondary outcome [3] 0 0
Mean change between treatment arms in Quality of Life Scores using the Rhinitis Control Assessment Test (RCAT)
Timepoint [3] 0 0
Baseline, 3 months post randomisation, 9 months post randomisation
Secondary outcome [4] 0 0
Change between treatment arms in participant knowledge, attitude and practice on nasal steroid and its uses
Timepoint [4] 0 0
Baseline, 3 months and 9 months post randomisation
Secondary outcome [5] 0 0
Change between treatment arms in total scores for participant INCS/INAH application technique
Timepoint [5] 0 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [6] 0 0
Change between treatment arms in participant engagement with educational resources from baseline to 3 months
Timepoint [6] 0 0
Baseline then at 1 month, 2 months, 3 months

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
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2026
Actual
Sample size
Target
194
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Murdoch Children's Research Institute - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Kirsten M Perrett, MBBS, FRACP, PhD
Address 0 0
Murdoch Childrens Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
National Allergy Centre of Excellence
Address 0 0
Country 0 0
Phone 0 0
61 3 99366752
Fax 0 0
Email 0 0
nace@mcri.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After the data has been cleaned and database has been locked, the de-identified data and if consented, personal identifying information, will be shared to National Allergy Centre of Excellence (NACE) Allergy BioRepository via a safe and secure mechanism, for storage and use in future allergy research.

Supporting document/s available: Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.nace.org.au/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06686446