Recruiting

Medilepsy® App

Sponsor:

University of Central Florida

Code:

NCT07445074

Conditions

Epilepsy

Seizure

Eligibility Criteria

Sex: All

Age: 14 - 24

Healthy Volunteers: Not accepted

Interventions

Medilepsy® Chatbot AI-Enhanced

Medilepsy® Chatbot Standard

Study Details

Brief summary:

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.

Conditions

Epilepsy

Seizure

Study ID

NCT07445074

Start date

May, 2026

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 24

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Medilepsy® Chatbot AI-Enhanced

Participants in the intervention group will use the AI-personalized version of the Medilepsy® app.

active comparator: Medilepsy® Chatbot Standard

Participants in the non-intervention group will use a standard version of the Medilepsy® app without AI functionality.

Interventions

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.

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 measure

  • Examine the effect of Medilepsy® with and without responsible AI design on medication adherence. [ Time Frame: 3-6 months ]

Central Contacts and Locations

Central contacts

Michelle Tall, PhD, RN, FAES

4077970555Michelle.Tall@UCF.edu

Amoy Fraser, PhD, CCRP, PMP

4072668742Amoy.Fraser@UCF.edu

Locations

Orlando Health Arnold Palmer Hospital

Recruiting

Orlando, Florida, United States, 32806

Contacts

Michelle Tall, PhD, RN, FAES

4077970100Michelle.Tall@UCF.edu

Orlando Health Orlando Regional Medical Center

Recruiting

Orlando, Florida, United States, 32806

Contacts

Michelle Tall, PhD, RN, FAES

4077970100Michelle.Tall@UCF.edu

Principal Investigator:

Michelle Tall, PhD, RN, FAES

More Information

Sponsor

University of Central Florida

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • Adherence
  • Anti-seizure medications
  • Artificial Intelligence
  • Chat-bot
  • Chronic disease
  • Epilepsy
  • Mobile Applications
  • Self-management
  • Seizures
  • Transition
  • Underserved

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Central Florida on 2026-05-29.