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NCT03817229 · ClinicalTrials.gov registry record · NA
Epilepsy Adherence in Children and Technology (eACT)
A NA study of Epilepsy, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 268
- Enrollment target
- 4
- Study locations
NCT03817229: Completed NA study of Epilepsy, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT03817229 is a NA study of Epilepsy that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 268 participants, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (72% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03817229, a NA study of Epilepsy, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 268 participants
- Enrollment target
- 4
- Study locations
Study Summary
Fifty-eight percent of children with new-onset epilepsy do not take their antiepileptic drugs (AEDs) as prescribed, which is associated with continued seizures, mortality, poor quality of life, and high healthcare costs. Evidence-based adherence interventions are lacking and critically needed, especially for children with epilepsy, who represent an underserved population in pediatrics. The current proposal is a mHealth sequential, multiple assignment, randomized trial (SMART) focused on providing education, automated digital reminders, and individualized adherence feedback, as well as teaching problem-solving skills, with the goal of improving adherence and quality of life and decreasing seizures and health care utilization.
Primary Outcome
Electronically monitored adherence, as measured by the Simplemed+ pillboxes or Adheretech bottles will be used as the primary outcome to calculate an adherence rate. A monthly adherence rate for antiseizure medication is calculated for Month 5, which ranges from 0-100%, with higher scores reflecting higher adherence.
Conditions Studied
Interventions
- BEHAVIORAL Education microlearning sessions
- BEHAVIORAL Automated digital reminders
- BEHAVIORAL Problem-solving mHealth module
- BEHAVIORAL Individualized Adherence Feedback Report
Study Locations (4)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
California
- Childrens Hospital of Orange County - Orange
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 268 participants |
| Start Date | 2019-04-15 |
| Est. Completion | 2024-08-01 |
| Phase | NA |
What the finished NCT03817229 record still lists
NCT03817229 is an interventional study that assigns participants to a tested intervention. The registered 268 participants enrollment target is mid-sized for trials with a published cap, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 4 interventions - of which Education microlearning sessions is the first listed.
NCT03817229 reports a single indexed study location in Ohio, California, South Carolina.
Frequently Asked Questions
What is clinical trial NCT03817229 about?
NCT03817229 is a clinical study titled "Epilepsy Adherence in Children and Technology (eACT)". Fifty-eight percent of children with new-onset epilepsy do not take their antiepileptic drugs (AEDs) as prescribed, which is associated with continued seizures, mortality, poor quality of life, and high healthcare costs. Evidence-based adherence interventions are lacking and critically needed, espec...
What is the current status of trial NCT03817229?
This trial is currently completed. It is a NA study. The enrollment target is 268 participants. The study started on 2019-04-15. Estimated completion is 2024-08-01.
What conditions does trial NCT03817229 study?
This clinical trial studies the following conditions: Epilepsy.
What interventions are being tested in trial NCT03817229?
The interventions under investigation include: Education microlearning sessions (BEHAVIORAL), Automated digital reminders (BEHAVIORAL), Problem-solving mHealth module (BEHAVIORAL), Individualized Adherence Feedback Report (BEHAVIORAL).
Who is sponsoring clinical trial NCT03817229?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03817229 being conducted?
This trial has 4 study locations across California, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03817229's enrollment target sits among peer trials
268 24th of 160 higher than 137 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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