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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 is a NA study that has completed, run by Indiana University. The registered enrollment target is 103 participants.

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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.

Interventions

  • BEHAVIORAL CHICA SUDEP module

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2018-06-14
Est. Completion 2019-03-30
Phase NA

Sponsor

Indiana University

890 total trials

What the Registry Record Tells You About NCT03502759

The ClinicalTrials.gov registry entry for NCT03502759 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which CHICA SUDEP module is the first listed.

NCT03502759 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.