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NCT Number: NCT07445074

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Chronic Disease Disease Attributes Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Seizure Seizures Signs and Symptoms

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orlando Health Arnold Palmer Hospital, Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medilepsy® Chatbot AI-Enhanced

Other

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

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. Examine the effect of Medilepsy® with and without responsible AI design on transition readiness skills.

    Time frame: 3-6 months

    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.

  2. Evaluate the usability of Medilepsy® at study completion.

    Time frame: 3-6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amoy Fraser, PhD, CCRP, PMP

CONTACT

[email protected]

4072668742

Michelle Tall, PhD, RN, FAES

CONTACT

[email protected]

4077970555

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

  • American Epilepsy Society
  • Orlando Health Arnold Palmer Hospital
  • Orlando Regional Medical Center

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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