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
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Enrollment
- 880
- Locations
- 1
- Primary Endpoint
- Comparing the proportion of subjects who maintain therapeutic persistence after completing 3 years of Immunotherapy treatment in the active and control groups
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: 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
Intervention: Inactive Adherence-booster App (Device)
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- 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)
Investigators
Pablo Rodríguez del Rio
Sponsor-Investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa