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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Device: Active Adherence-booster App; Device: Inactive Adherence-booster App

• Study Type: Interventional
• Enrollment (Estimated): 880
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pablo Rodríguez del Río, MD PhD; Phone Number: +34915035900; Email: prrio@yahoo.es

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28010
      • Recruiting
      • Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65
      • Contact: Pablo Rodríguez del Río; Phone Number: +34915035900; Email: prrio@yahoo.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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
Other: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing the proportion of subjects who maintain therapeutic persistence after completing 3 years of Immunotherapy treatment in the active and control groups	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	From entry to the end of study period at 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Self-reported implementation data will be collected using a 7 point scale, where 1 represents the best implementation possible (100% of doses correctly taken) and 7 represents treatment withdrawal (0% of doses taken). Intermediate implementation levels vary to complete the scale	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	Patients withdrawing AIT will be invited to select one or more reasons for treatment discontinuation: i) AIT Adverse Events, ii) Insufficient AIT efficacy, iii) Considering AIT sufficiently efficacious as to prematurely withdrawn the treatment, iv) AIT costs, v) Lack of sufficient baseline allergy severity as to have started the treatment, vi) AIT schedule interfering patient´s lifestyle, vii) Insufficient adherence, viii) AIT discontinuated by the patient´s allergist, ix) Other reasons	From entry to the end of study period at 3 years

Collaborators and Investigators

• Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Collaborators: Fundación para la investigación biomética Hospital Infantil Universitario Niño Jesús

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): March 11, 2030
• Study Completion (Estimated): March 11, 2030

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Adherence; Implementation; subcutaneous; Mobile App; sublingual; Allergic rhinitis; allergen immunotherapy; SCIT; SLIT; pollen; grass; mites; AIT; Respiratory allergy; Persistance; Real life study; animal dander
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: R-0010/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No