About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Medilepsy® Chatbot AI-Enhanced
Other interventionParticipants 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.
Medilepsy® Chatbot Standard
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Examine the effect of Medilepsy® with and without responsible AI design on medication adherence.
Participants will demonstrate significant improvement in medication adherence measured by Medication adherence rate (MAR) formula: The average number of missed medications. Adherence Rate (%) = (Number of prescribed ASM doses taken / Number of prescribed ASM doses scheduled) × 100.
Secondary outcomes
Examine the effect of Medilepsy® with and without responsible AI design on transition readiness skills.
Participants will demonstrate significant improvement in transition readiness measured by Transition Readiness Assessment Questionnaire (TRAQ) scores: A validated tool/ 5-point Likert scale measuring transition skills across five domains: managing medications, appointment keeping, tracking health issues, communicating with providers, and managing daily activities.
Evaluate the usability of Medilepsy® at study completion.
Participants usability score will be greater than 83% out of 0-100% measured by MHealth App Usability Questionnaire (MAUQ) scores: A validated tool consists of 18 questions rated on a 7-point Likert scale assessing ease of use, usefulness, interface quality, and satisfaction. Higher scores indicate better usability.
Sponsors and contacts
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University of Central Florida
Lead sponsor
American Epilepsy Society
Collaborator
Orlando Regional Medical Center
Collaborator
Orlando Health Arnold Palmer Hospital
Collaborator