A Simulation-based Intervention for Caregivers of Children With Seizures

NCT01831063 | Completed

• 1 other identifier: Alberta Children's Hospital
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Caregivers of children with seizures receiving simulation based seizure management teaching in addition to the traditional seizure teaching will report more confidence with seizure management and demonstrate a higher level of performance with seizure management.

Conditions

Dependency on Medications Prescribed for Patient; Types of Seizures and Epileptic Syndromes

Keywords

Seizure; Caregivers; Family Centered Care; Learning modality

Outcome Measures

Primary Outcomes (1)

• KidSIM Emergent Seizure Management Checklist

  Caregivers performance managing a seizure scenario was assessed at baseline and at 48 hours after which time caregivers received their respective teaching sessions. Caregivers in the both groups participated in the traditional seizure teaching sessions. Caregivers in the intervention group received an additional simulation-based seizure teaching session that consisted of opportunities to practice seizure management in a simulated environment with instructor feedback and guidance. These sessions generally lasted 30 minutes and were deemed complete when caregivers were able to verbalize confidence with seizure management. The performance of caregivers in both groups were assessed again immediately after they received their respective teaching sessions which was usually the day of discharge.

  Baseline, 48 hours and 6 months

Secondary Outcomes (1)

• The Aspire KidSIM Parent Seizure Self-efficacy Questionnaire

  Baseline , 48 hours and 6 months

Study Arms (2)

1

NO INTERVENTION

This group received the traditional seizure teaching. This consisted of verbal instruction from health care professionals on acute seizure management and administration of the rescue medication.

2

EXPERIMENTAL

This group received the traditional seizure teaching as well as the supplemental simulation based seizure management teaching. The simulation based seizure teaching consisted of numerous opportunities to manage a simulated seizure with instructor guidance and feedback. This session was deemed complete when caregivers verbalized confidence with seizure management.

Behavioral: Simulation

Interventions

Simulation BEHAVIORAL

The experimental group received a simulation based seizure teaching session in addition to the traditional seizure teaching

2

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of Seizure disorder
• Dependence on a anti-seizure medication

You may not qualify if:

• No dependence on rescue medication

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B6A8, Canada

Location

MeSH Terms

Conditions

Epileptic Syndromes; Seizures

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elaine Sigalet, PhD

  Alberta Children's Hospital

  PRINCIPAL INVESTIGATOR

• Vincent Grant, MD

  Alberta Children's Hospital, University of Calgary

  PRINCIPAL INVESTIGATOR

• Adam Cheng, MD

  Alberta Children's Hospital, University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and Development ASPIRE/KidSIM Simulation Program Alberta Children's Hospital, Associate Professor Pediatrics

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 15, 2013
• Study Start: October 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 15, 2013

Record last verified: 2013-04

Locations

CA (1)