Pragmatic Randomized Prospective Clinical Study to Evaluate the Effectiveness of a Digital Application to Improve Aeroallergen Immunotherapy Adherence in Real Life. The NavigAITme Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 880
- 试验地点
- 1
- 主要终点
- Comparing the proportion of subjects who maintain therapeutic persistence after completing 3 years of Immunotherapy treatment in the active and control groups
研究概览
简要总结
Aaeroallergen Immunotherapy (AIT) is indicated in the treatment of allergic rhinitis and asthma, and has shown efficacy to control symptoms and induce immunomodulatory changes that support post discontinuation efficacy. Data from clinical trials provides founding for its efficacy and safety profile, but the therapy needs to be withheld for a minimum of 3 years, with modalities that imply daily or near daily administration of a sublingual extract, or subcutaneous injections, every 4 to 6 weeks. This treatment regimen often faces other limitations such as cost, patient´s lack of knowledge regarding efficacy/safety, or potentiality of adverse reactions. These factors have been pointed out as main reasons for a reported low level of treatment adherence in real life.
While overall literature data on treatment adherence ranges widely, from 6% to 93% of patients finalising the minimum of 3 years, current data from precise German registries inform of persistence at 3 years being very low, varying from 5.2% to 18.2% with differences depending on extract, route and patient´s age.
Surprisingly, even if the Scientific community acknowledges patient adherence as a very relevant weak point, there´s paucity of structured strategies to tackle this issue, and those available, have mostly been developed in single centers, for periods below the 3 years of AIT recommended duration. In the era of technology, and with the spreading of mobile applications (App), new approaches are currently ongoing to counteract this important drawback . In this landscape, this study aims at creating a new App that will be thoroughly tested in a prospective long-term randomized trial, to improve AIT persistence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of any age and sex
- •Patients who have received their first prescription for a new aeroallergen immunotherapy treatment as part of their routine care for allergic rhinitis with or without asthma
- •Patients who have been prescribed only a single immunotherapy product
- •Patients who have been prescribed a commercially available product, from any company, for sublingual or subcutaneous administration
- •Patients who have provided the first photograph of the product for which they are entering the study
排除标准
- •Patients receiving AIT prescription for asthma only, and do not suffer allergic rhinitis
- •Administration routes other than subcutaneous or sublingual
- •Patients receiving AIT prescription for other indications, e.g., food or hymenoptera allergies
- •Patients who have received immunotherapy in the last 3 years or are currently undergoing treatment with an AIT product other than the one being studied in the current project.
- •Patients who have received prescription for two or more different immunotherapy products simultaneously
研究组 & 干预措施
Active Group
This is the arm of the study where patients will receive the intervention, ie: adherence-booster App. All participants in this arm will download the mobile App. This App will have two main objectives:
i) deliver the intervention, mainly messages to improve patient´s education on allergic conditions and Aeroallergen Immunotherapy as well as administration and purchase reminders.
ii) serve as electronic Case Report Form allowing patients providing feedback to inform study variables
干预措施: Active Adherence-booster App (Device)
Control Group
This is the arm of the study where patients will NOT receive the intervention, ie: adherence-booster App. All participants in this arm will download the mobile App. This App will have only one objective:
i) serve as electronic Case Report Form allowing patients providing feedback to inform study variables
干预措施: Inactive Adherence-booster App (Device)
结局指标
主要结局
Comparing the proportion of subjects who maintain therapeutic persistence after completing 3 years of Immunotherapy treatment in the active and control groups
时间窗: From entry to the end of study period at 3 years
Persistence definition: time from the moment of delivery of the first product, until the estimated time of completion of the last product delivered. This definition has been previously used in this field. A difference of 15% between active and control groups will be considered as clinically meaningful, denoting success of the intervention
次要结局
- Comparing the proportion of subjects who maintain therapeutic persistence after completing 2 years of Immunotherapy treatment in the active group vs control group(From entry to the end of second year of study period)
- Comparing the proportion of subjects who maintain therapeutic persistence after completing 1 years of Immunotherapy treatment in the active group vs control group(From entry to the end of first year of study period)
- Comparing the therapeutic self-reported implementation between persistent subjects after completing 3 years of Immunotherapy in the active group vs. the control group(From entry to the end of study period at 3 years)
- Comparing AIT discontinuation reasons in non-persistent patients (ie, withdrawing the treatment), after 3 years of study will be collected(From entry to the end of study period at 3 years)
研究者
Pablo Rodríguez del Rio
Sponsor-Investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa