A Simulation-based Intervention for Caregivers of Children With Seizures

April 12, 2013 updated by: Adam Cheng, University of Calgary

Simulation for Family Centered Care: Improving Caregivers Skills, Self-Efficacy and Quality of Life Using a Practice-Until-Perfect Simulation Intervention for Seizure Management in the Home Environment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B6A8
        • Alberta Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

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

Exclusion Criteria

  • No dependence on rescue medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
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.
Experimental: 2
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
The experimental group received a simulation based seizure teaching session in addition to the traditional seizure teaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KidSIM Emergent Seizure Management Checklist
Time Frame: Baseline, 48 hours and 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Aspire KidSIM Parent Seizure Self-efficacy Questionnaire
Time Frame: Baseline , 48 hours and 6 months
Caregivers were asked to fill out the questionnaire at baseline and after they received their respective teaching sessions which was at 48 hours post baseline.
Baseline , 48 hours and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 1, 2013

First Submitted That Met QC Criteria

April 12, 2013

First Posted (Estimate)

April 15, 2013

Study Record Updates

Last Update Posted (Estimate)

April 15, 2013

Last Update Submitted That Met QC Criteria

April 12, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alberta Children's Hospital

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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