Evaluation of a Digital Tool to Improve Aeroallergen Immunotherapy Adherence. NavigAITme Project

Official title

Pragmatic Randomized Prospective Clinical Study to Evaluate the Effectiveness of a Digital Application to Improve Aeroallergen Immunotherapy Adherence in Real Life. The NavigAITme Project

Overview

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.

Interventions

• Device Active Adherence-booster App
  The Active Adherence-booster App includes an array of short messages that will be delivered to the active arm participants to tackle previously reported factors negatively influencing adherence in AIT, such as patient´s knowledge on Allergic rhinitis and AIT as well as administration and purchase reminders. The App will also serve as electronic Case Report Form
• Device Inactive Adherence-booster App
  The Inactive Adherence-booster App does not include any of the messages or intervention of the Active version. The App only serves as electronic Case Report Form

Primary outcome measures

• Comparing the proportion of subjects who maintain therapeutic persistence after completing 3 years of Immunotherapy treatment in the active and control groups [Time frame: From entry to the end of study period at 3 years]

Secondary outcome measures (4)

• Comparing the proportion of subjects who maintain therapeutic persistence after completing 2 years of Immunotherapy treatment in the active group vs control group [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From entry to the end of study period at 3 years]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Spain · 1 center

• Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65 — Madrid

Identifiers

NCT: NCT07419230 · R-0010/25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗