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Digital Adherence Tools for Pediatric Epilepsy (eACT Trial)
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 belowSelect...
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
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
Find a Location
Who is running the clinical trial?
Nationwide Children's HospitalOTHER
341 Previous Clinical Trials
5,220,033 Total Patients Enrolled
3 Trials studying Epilepsy
109 Patients Enrolled for Epilepsy
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,530,204 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a major condition like Autism or diabetes.My child is between 2 and 12 years old.I plan to gradually stop taking my epilepsy drugs over 18 months.I was diagnosed with epilepsy less than 2 years ago.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Treatment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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