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NCT01851057 · ClinicalTrials.gov registry record · NA
Supporting Treatment Adherence Regimens in Pediatric Epilepsy: The STAR Trial
A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
NCT01851057: Completed NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT01851057 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01851057, a NA study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
Study Summary
Fifty-eight percent of children with new-onset epilepsy do not take their antiepileptic drugs (AEDs) as prescribed (i.e., non-adherence). Non-adherence, which is modifiable, is associated with continued seizures, mortality, poor quality of life, and high healthcare costs. There are no adherence interventions for young children with epilepsy and their families; thus, the current proposal examines a family-based behavioral treatment focused on improving epilepsy knowledge and problem-solving around barriers to adherence in young children with epilepsy and their families with the goal of improving adherence and ultimately, seizures and quality of life. It is hypothesized that children with newly diagnosed epilepsy and their families who participate in the problem-solving intervention will have significant improvements on adherence compared to those in the education only intervention.
Primary Outcome
This is a measure of adherence, using an electronic monitor called the Medication Event Monitoring System (MEMS) TrackCap, and adherence rates range from 0 to 100%. Adherence rates will be calculated at baseline and represent a rate from 0 to 100. Similarly, an adherence rate will be calculated for the 30 day post intervention period, with a rate between 0-100%. The change score for the mean of the 30 days of adherence immediately following the end of intervention relative to the mean adherence
Interventions
- BEHAVIORAL STAR
- BEHAVIORAL Education Only
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2013-04 |
| Est. Completion | 2019-12 |
| Phase | NA |
What the finished NCT01851057 record still lists
NCT01851057 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which STAR is the first listed.
NCT01851057 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01851057 about?
NCT01851057 is a clinical study titled "Supporting Treatment Adherence Regimens in Pediatric Epilepsy: The STAR Trial". Fifty-eight percent of children with new-onset epilepsy do not take their antiepileptic drugs (AEDs) as prescribed (i.e., non-adherence). Non-adherence, which is modifiable, is associated with continued seizures, mortality, poor quality of life, and high healthcare costs. There are no adherence inte...
What is the current status of trial NCT01851057?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2013-04. Estimated completion is 2019-12.
What interventions are being tested in trial NCT01851057?
The interventions under investigation include: STAR (BEHAVIORAL), Education Only (BEHAVIORAL).
Who is sponsoring clinical trial NCT01851057?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01851057's enrollment target sits among peer trials
200 506th of 2000 higher than 1,434 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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