The Role of Patient Education and Adherence Aids during Combination Intranasal Treatments for Allergic Rhinitis - the REPEAT-AR Trial

This is a prospective, interventional, randomised trial, evaluating the impact and effectiveness of a new INCS/INAH education package to enhance compliance to AR treatment, in comparison to the standard of care education that is currently provided. A decentralized clinical trial model will be used. The primary site will be responsible for enrolling participants supported by recruitment sites across Australia. Patients aged 14-29 years old will be recruited following initial standard consultations and confirmation of moderate to severe AR diagnosis, defined by clinical documentation and a positive skin prick test for one or more aeroallergens. The treating clinician will inform their patients about the study and provide them with recruitment aids to register their interest and receive more information. If they wish to know more about the study, they will be able to register their interest via an online form. The primary study nurse 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 Package (SEP) that they receive from their treating physician. The EEP includes the standard of care education package with the additional intervention of advanced patient education toolkit and compliance aids delivered by email/SMS.
Nasal and ocular symptom scores will be collected and validated quality-of-life and knowledge -attitude-practice (KAP) questionnaires will be completed by all participants at baseline and 3-months. To look at longer term efficacy of the education and compliance aids, all participants will be followed up 9 months post-randomisation.