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NCT03502759 · ClinicalTrials.gov registry record · NA
Improving Patient Communication About SUDEP
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 103
- Enrollment target
NCT03502759: Completed NA study, sponsored by Indiana University.
NCT03502759 is a NA study that has completed, run by Indiana University. The registered enrollment target is 103 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03502759, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 103 participants
- Enrollment target
Study Summary
Children with generalized tonic-clonic seizures (GTCS) have about a 1 in 4500 of succumbing to sudden unexpected death in epilepsy (SUDEP). For that reason, the American Academy of Neurology recommends that clinicians caring for these children make their families aware of this small but important risk and provide appropriate supportive follow-up resources. Moreover, existing evidence suggests that children with poorly controlled GTCS have a strikingly increased odds of SUDEP, 3-24 fold, raising the importance of improving seizure control. Clinicians caring for these patients have multiple issues to address in the typical visit. The investigators propose to use information technology to help providers assure that addressing SUDEP is incorporated into their routine care. The investigators have developed the Child Health Improvement through Computer Automation system (CHICA), a computer based clinical decision support system for pediatric care. CHICA captures patient reported data in the waiting room and prioritizes clinical advice to the physician through the electronic health record (EHR). CHICA is used in five primary care clinics in the Eskenazi health system where it supports general pediatric care. The goal of this project is to test the effectiveness of a SUDEP module in this setting where CHICA is already in use - with a future goal of developing a full suite of CHICA modules for child neurologists.
Primary Outcome
Parents will be contacted by phone and answer survey questions about SUDEP counseling during their child's most recent pediatric visit.
Interventions
- BEHAVIORAL CHICA SUDEP module
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2018-06-14 |
| Est. Completion | 2019-03-30 |
| Phase | NA |
What the finished NCT03502759 record still lists
NCT03502759 is an interventional study that assigns participants to a tested intervention. The registered 103 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 (93% lower).
The record links to 0 conditions, and to 1 intervention - of which CHICA SUDEP module is the first listed.
NCT03502759 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03502759 about?
NCT03502759 is a clinical study titled "Improving Patient Communication About SUDEP". Children with generalized tonic-clonic seizures (GTCS) have about a 1 in 4500 of succumbing to sudden unexpected death in epilepsy (SUDEP). For that reason, the American Academy of Neurology recommends that clinicians caring for these children make their families aware of this small but important ri...
What is the current status of trial NCT03502759?
This trial is currently completed. It is a NA study. The enrollment target is 103 participants. The study started on 2018-06-14. Estimated completion is 2019-03-30.
What interventions are being tested in trial NCT03502759?
The interventions under investigation include: CHICA SUDEP module (BEHAVIORAL).
Who is sponsoring clinical trial NCT03502759?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03502759's enrollment target sits among peer trials
103 837th of 2000 higher than 1,164 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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