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Digital Adherence Tools for Pediatric Epilepsy (eACT Trial)

Q: Are individuals aged 50 or older eligible for this experiment?

The age requirements for participants in this study are between 2 and 12 years old.

Q: Has the FDA signed off on Individualized Adherence Feedback Report?

There is some data supporting the safety of Individualized Adherence Feedback Report, but none yet backing up its efficacy. We've given it a score of 2.

Q: How many individuals are enrolling in this research?

The information available on clinicaltrials.gov suggests that this research is still looking for volunteers. The trial was first advertised on April 15th, 2019 and has since been updated on March 30th, 2022. They need 600 participants in total, which will be recruited from 4 hospitals or clinics.

Q: Are there any specific requirements for subjects in this trial?

This trial, which is looking to enroll 600 patients in total, is open to those aged 2-12 that suffer from aura.

Q: Can people with the qualifying medical condition still enroll in this research project?

That is correct. The clinical trial, which was first posted on 4/15/2019 and updated as recently as 3/30/2022, is actively recruiting patients. They are looking for 600 participants total from 4 different locations.

Q: How many research facilities are coordinating this project?

4 trial sites are currently enrolling patients for this study. The locations of these centres are Cincinnati, Charleston, Columbus and 4 other undisclosed locations. If you wish to participate in the clinical trial, it is advised that you select the nearest location to reduce travel time commitment.

N/A

Waitlist Available

Led By Avani Modi, Ph.D.

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children ages 2-12 years

Epilepsy diagnosis < 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 8-20

Awards & highlights

eACT Trial Summary

This trial will test a new way to help kids with epilepsy take their medication as prescribed. The hope is that this will lead to fewer seizures and a better quality of life.

Who is the study for?

This trial is for children aged 2-12 years who have been diagnosed with epilepsy within the last two years and can read/speak English. It's not suitable for kids with major neurodevelopmental or medical disorders like autism or diabetes, or those planning to stop their epilepsy drugs in the next 18 months.Check my eligibility

What is being tested?

The eACT study uses mobile health technology to improve how well children take their epilepsy medication. It includes educational sessions, automated reminders, personalized feedback on medication use, and problem-solving tools designed to help manage treatment better.See study design

What are the potential side effects?

Since this trial focuses on adherence through digital means rather than new medications, side effects are minimal but may include stress or anxiety from regular reminders and monitoring of drug intake.

eACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 2 and 12 years old.

Select...

I was diagnosed with epilepsy less than 2 years ago.

eACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 8-20

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 8-20

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 8-20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence rates

Secondary outcome measures

Seizures

Healthcare utilization (the number of emergency room visits and hospitalizations)

PedsQL Epilepsy Module (health-related quality of life measure)

eACT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment GroupExperimental Treatment4 Interventions

mHealth education module, automated digital reminders, and individualized adherence feedback (stage 1 SMART). After three months of intervention, the treatment group will be evaluated for responsiveness (> 95%) based on the 30-day adherence outcome (stage 2 SMART). If participants in the treatment group demonstrate adherence > 95%, they will continue with the treatment arm of receiving automated digital reminders and individualized adherence feedback. If they are deemed to be non-responsive (adherence < 95%), they will be re-randomized to either: 1) continued automated digital reminders and individualized adherence feedback or 2) a mHealth problem solving module with three therapist-guided problem-solving sessions.

Group II: Control GroupActive Control2 Interventions

mHealth education module and automated digital reminders

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Individualized Adherence Feedback Report

2019

N/A

~110

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalOTHER

341 Previous Clinical Trials

5,220,037 Total Patients Enrolled

3 Trials studying Epilepsy

109 Patients Enrolled for Epilepsy

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,130 Total Patients Enrolled

13 Trials studying Epilepsy

1,879 Patients Enrolled for Epilepsy

Children's Hospital of Orange CountyOTHER

32 Previous Clinical Trials

4,468 Total Patients Enrolled

2 Trials studying Epilepsy

210 Patients Enrolled for Epilepsy

Media Library

Automated digital reminders Clinical Trial Eligibility Overview. Trial Name: NCT03817229 — N/A

Epilepsy Research Study Groups: Control Group, Treatment Group

Epilepsy Clinical Trial 2023: Automated digital reminders Highlights & Side Effects. Trial Name: NCT03817229 — N/A

Automated digital reminders 2023 Treatment Timeline for Medical Study. Trial Name: NCT03817229 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 50 or older eligible for this experiment?

"The age requirements for participants in this study are between 2 and 12 years old."

Answered by AI

Has the FDA signed off on Individualized Adherence Feedback Report?

"There is some data supporting the safety of Individualized Adherence Feedback Report, but none yet backing up its efficacy. We've given it a score of 2."

Answered by AI

How many individuals are enrolling in this research?

"The information available on clinicaltrials.gov suggests that this research is still looking for volunteers. The trial was first advertised on April 15th, 2019 and has since been updated on March 30th, 2022. They need 600 participants in total, which will be recruited from 4 hospitals or clinics."

Answered by AI

Are there any specific requirements for subjects in this trial?

"This trial, which is looking to enroll 600 patients in total, is open to those aged 2-12 that suffer from aura."

Answered by AI

Can people with the qualifying medical condition still enroll in this research project?

"That is correct. The clinical trial, which was first posted on 4/15/2019 and updated as recently as 3/30/2022, is actively recruiting patients. They are looking for 600 participants total from 4 different locations."

Answered by AI

How many research facilities are coordinating this project?

"4 trial sites are currently enrolling patients for this study. The locations of these centres are Cincinnati, Charleston, Columbus and 4 other undisclosed locations. If you wish to participate in the clinical trial, it is advised that you select the nearest location to reduce travel time commitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Epilepsy Adherence in Children and Technology (eACT)

2019. "Epilepsy Adherence in Children and Technology (eACT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03817229.

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