Digital app to improve adherence to aeroallergen immunotherapy
Pragmatic Randomized Prospective Clinical Study to Evaluate the Effectiveness of a Digital Application to Improve Aeroallergen Immunotherapy Adherence in Real Life. The NavigAITme Project
This project will test whether a smartphone app can help people with allergic rhinitis keep taking their prescribed aeroallergen immunotherapy for the full treatment course.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 880 (estimated) |
| Sex | All |
| Sponsor | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT07419230 on ClinicalTrials.gov |
What this trial studies
Participants who are starting a new sublingual or subcutaneous aeroallergen immunotherapy as part of routine care will be assigned to either an active adherence‑booster app or an inactive app. The active app offers reminders, educational content, and photo-based product confirmation to encourage persistence, while the inactive app provides minimal or no adherence support. Researchers will track how well participants stick with their prescribed immunotherapy over the treatment period and compare adherence between groups. Recruitment and follow-up are conducted at participating hospitals in Madrid.
Who should consider this trial
Good fit: People of any age with allergic rhinitis (with or without asthma) who are starting a new, single commercial sublingual or subcutaneous aeroallergen immunotherapy and can provide a first photo of the product are ideal candidates.
Not a fit: Patients prescribed AIT for asthma only, those treated for food or hymenoptera allergies, those using routes other than sublingual/subcutaneous, or those who recently received AIT within 3 years (or who cannot use the app) are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, the app could increase adherence to aeroallergen immunotherapy, leading to better symptom control and more durable benefit after treatment ends.
How similar studies have performed: Digital adherence tools have improved medication adherence in other chronic conditions, but evidence specifically showing benefit for aeroallergen immunotherapy adherence is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madrid, Madrid
- Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65 — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Pablo Rodríguez del Río, MD PhD
- Email: prrio@yahoo.es
- Phone: +34915035900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.