EpilepsyNCT07445074
AI-Based Mobile Intervention on Medication Non-Adherence and Transition
A study testing Medilepsy® Chatbot AI-Enhanced and Medilepsy® Chatbot Standard in people with Epilepsy and Seizure, run by University of Central Florida at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 24 years
- What is being tested?
- Medilepsy® Chatbot AI-Enhanced and Medilepsy® Chatbot Standard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Orlando Health Arnold Palmer Hospital
Orlando, Florida, 32806
Michelle Tall, PhD, RN, FAES, 4077970100, Michelle.Tall@UCF.edu
- Recruiting
Orlando Health Orlando Regional Medical Center
Orlando, Florida, 32806
Michelle Tall, PhD, RN, FAES, 4077970100, Michelle.Tall@UCF.edu
Michelle Tall, PhD, RN, FAES
About this study
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.
- Being tested
- Medilepsy® Chatbot AI-Enhanced, Medilepsy® Chatbot Standard
- Keywords
- Adherence, Anti-seizure medications, Artificial Intelligence, Chat-bot, Chronic disease, Epilepsy, Mobile Applications, Self-management, Seizures, Transition, Underserved
- Medical subject headings
- Epilepsy, Seizures, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medilepsy® Chatbot AI-EnhancedOther
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 StandardOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Medilepsy® Chatbot AI-Enhanced | Experimental | Participants in the intervention group will use the AI-personalized version of the Medilepsy® app. Receives: 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. Receives: Other: Medilepsy® Chatbot Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-6 months
Secondary outcomes (2)
Examine the effect of Medilepsy® with and without responsible AI design on transition readiness skills.
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.
Measured: 3-6 months
Evaluate the usability of Medilepsy® at study completion.
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.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- American Epilepsy Society, Orlando Regional Medical Center, Orlando Health Arnold Palmer Hospital
- Responsible party
- Sponsor
- Investigators
- Michelle Tall, PhD, RN, FAES, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445074
- Sponsor's protocol ID
- STUDY00007881
- Status last verified
- May 2026
- First submitted
- 18 Feb 2026
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Based Mobile Intervention on Medication Non-Adherence and Transition
- ClinicalTrials.gov ID
- NCT07445074
- Acronym / sponsor ID
- STUDY00007881
- Keywords
- Adherence, Anti-seizure medications, Artificial Intelligence, Chat-bot, Chronic disease, Epilepsy, Mobile Applications, Self-management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- American Epilepsy Society, Orlando Regional Medical Center, Orlando Health Arnold Palmer Hospital
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medilepsy® Chatbot AI-Enhanced | Experimental | Other: Medilepsy® Chatbot AI-EnhancedParticipants in the intervention group will use the AI-personalized version of the Medilepsy® app. |
| Medilepsy® Chatbot Standard | Active comparator | Other: Medilepsy® Chatbot StandardParticipants in the non-intervention group will use a standard version of the Medilepsy® app without AI functionality. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medilepsy® Chatbot AI-EnhancedParticipants 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 AI-Enhanced |
| Medilepsy® Chatbot StandardParticipants 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. | Other | Medilepsy® Chatbot Standard |
Primary outcome
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.
2 secondary outcomes
Examine the effect of Medilepsy® with and without responsible AI design on transition readiness skills.
Time frame: 3-6 months
Evaluate the usability of Medilepsy® at study completion.
Time frame: 3-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Tall, PhD, RN, FAES principal investigator
University of Central Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medilepsy® Chatbot AI-Enhanced and Medilepsy® Chatbot Standard in people with Epilepsy and Seizure, run by University of Central Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Tall, PhD, RN, FAES (4077970555, Michelle.Tall@UCF.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine the effect of Medilepsy® with and without responsible AI design on medication adherence. (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.