NCT07419230

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 880 (estimated)
• Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-03-11
• Primary completion: 2030-03-11
• Completion: 2030-03-11
• First posted: 2026-02-18
• Last updated: 2026-03-23

Locations

1 site across 1 country: Spain