NCT07445074 · University of Central Florida
AI-Based Mobile Intervention on Medication Non-Adherence and Transition
What this study is about
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.
View original scientific description
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
Where
- Orlando, Florida
Collaborators
American Epilepsy Society, Orlando Regional Medical Center, Orlando Health Arnold Palmer Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 29, 2026 · Source of record for eligibility and locations