Allergic Rhinitis Improvement Through Strategic Education: The ARISE Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
This study will be a prospective decentralised interventional trial that will address the following research question: In adolescents and young adults with moderate to severe AR does six weeks of a targeted intervention package of patient education tools reduce AR symptoms and positively impact other patient reported outcomes compared to standard AR management?
Trial participants aged 14-29 will be recruited via both direct to patient advertising and participating recruitment sites (for example, allergy specialists, hospital outpatient clinics and general practitioners), located across Australia.
Participants will be currently experiencing AR symptoms of at least moderate to severe severity (as per ARIA guidelines), have a previous positive SPT and/or sIgE to at least one aeroallergen, and will be using or about to start using either a INCS or a combined INCS+INAH spray.
Patients interested in participating in the trial will be able to register their interest via an online webform and complete a few eligibility screening questions. The central study team will then undertake an informed consent process via telehealth. As part of informed consent, participants are asked to allow the study team to request access to their skin prick test and/or sIgE results. 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). All participants will be assessed at baseline and 6 weeks post-randomisation on physical symptoms (nasal and ocular symptoms) and quality of life. A validated questionnaire to assess knowledge, attitude and practice (KAP) of nasal steroid and its uses, will also be given to all participants in each group at both timepoints. All assessment measures will be repeated at 9-months post-randomisation to look at longer term outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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 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
干预措施: Enhanced Education Package (Behavioral)
Standard of care
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.
结局指标
主要结局
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
时间窗: Baseline and 6-weeks post-randomisation
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.
次要结局
- 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 total scores for participant INCS or INCS+INAH application technique(Baseline, 6 weeks and 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 participant engagement with educational resources from baseline to 6 weeks(Baseline then at 2 weeks, 4 weeks, 6 weeks)