AI-Based Mobile Intervention on Medication Non-Adherence and Transition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medilepsy® Chatbot AI-Enhanced, Medilepsy® Chatbot Standard.
- Who it may be relevant to
- Registry conditions: Epilepsy, Seizure. Basic parameters: 14 years — 24 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study aims to examine whether the AI-personalized version of the Medilepsy® app is more effective than the non-AI (standard version without AI personalization) can improve key outcomes, such as medical adherence and transition readiness, among underserved adolescents and young adults with epilepsy, ages 14-24, in Florida, USA. Outcomes are organized into primary (effectiveness), secondary (usability), and exploratory (language experience) endpoints.
Interventions
- Other Medilepsy® Chatbot AI-Enhanced
Participants in the intervention group will use the AI-personalized version of the Medilepsy® app, which includes a Smart Chatbot that delivers interactive support based on user-entered data. The chatbot offers personalized prompts, relevant topic suggestions, and adaptive educational content to support epilepsy self-management. - Other Medilepsy® Chatbot Standard
Participants in the non-intervention group will use a standard version of the Medilepsy® app without AI functionality. This version includes static prompts and general educational links but does not provide personalized feedback or adaptive interaction.
Primary outcome measures
- Examine the effect of Medilepsy® with and without responsible AI design on medication adherence. [Time frame: 3-6 months]
Secondary outcome measures (2)
- Examine the effect of Medilepsy® with and without responsible AI design on transition readiness skills. [Time frame: 3-6 months]
- Evaluate the usability of Medilepsy® at study completion. [Time frame: 3-6 months]
Eligibility criteria
Inclusion criteria
- Diagnosed with epilepsy
- Currently prescribed anti-seizure medicine (ASMs)
- Identified as part of an underserved population, defined as meeting at least one of the following: member of a racial or ethnic group historically underrepresented in research or healthcare or low-income status (e.g., eligible for public assistance or government-subsidized health coverage)
- Are between 14-17 years old and able to provide assent, with a parent or LAR present to receive app notifications throughout the study
- Are between 18-24 years old and able to provide informed consent
- Able to read, speak, and write in English
- Resides in Florida
- Receive outpatient medical services
Exclusion criteria
- They do not own a mobile device with internet access.
- They have a history of severe intellectual disability.
- They are unable to operate a mobile device (keyboard or touchscreen).
- Reside in an in-patient setting.
- Adults unable to consent.
- Pregnant women (excluded because pregnancy is not relevant to the study focus).
- Prisoners.
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
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Orlando Health Arnold Palmer Hospital — Orlando
- Orlando Health Orlando Regional Medical Center — Orlando
Identifiers
NCT: NCT07445074 · STUDY00007881