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

NCT07445074 | Recruiting

• 1 other identifier: STUDY00007881
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3-6 months

Secondary Outcomes (2)

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

  3-6 months

• Evaluate the usability of Medilepsy® at study completion.

  3-6 months

Study Arms (2)

Medilepsy® Chatbot AI-Enhanced

EXPERIMENTAL

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

Other: Medilepsy® Chatbot AI-Enhanced

Medilepsy® Chatbot Standard

ACTIVE COMPARATOR

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

Other: Medilepsy® Chatbot Standard

Interventions

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 AI-Enhanced

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.

Medilepsy® Chatbot Standard

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orlando Regional Medical Center: collaborator
• American Epilepsy Society: collaborator
• Orlando Health Arnold Palmer Hospital: collaborator
• University of Central Florida: lead

Study Sites (2)

Orlando Health Arnold Palmer Hospital

Orlando, Florida, 32806, United States

RECRUITING

Orlando Health Orlando Regional Medical Center

Orlando, Florida, 32806, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy; Seizures; Chronic Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Michelle Tall, PhD, RN, FAES

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Tall, PhD, RN, FAES

CONTACT

4077970555; Michelle.Tall@UCF.edu

Amoy Fraser, PhD, CCRP, PMP

CONTACT

4072668742; Amoy.Fraser@UCF.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: March 3, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

US (2)