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

May 27, 2026 updated by: University of Central Florida

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Orlando Regional Medical Center
        • Principal Investigator:
          • Michelle Tall, PhD, RN, FAES
        • Contact:
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Arnold Palmer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medilepsy® Chatbot AI-Enhanced
Participants in the intervention group will use the AI-personalized version of the Medilepsy® app.
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.
Active Comparator: Medilepsy® Chatbot Standard
Participants in the non-intervention group will use a standard version of the Medilepsy® app without AI functionality.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3-6 months
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.
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Central Florida

Collaborators

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

Investigators

  • Principal Investigator: Michelle Tall, PhD, RN, FAES, University of Central Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007881

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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