A Simulation-based Intervention for Caregivers of Children With Seizures

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Behavioral: Simulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Clinical diagnosis of Seizure disorder Dependence on a anti-seizure medication Exclusion Criteria No dependence on rescue medication

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>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<br>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<br>* The experimental group received a simulation based seizure teaching session in addition to the traditional seizure teaching<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Aspire KidSIM Parent Seizure Self-efficacy Questionnaire | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seizure, Caregivers, Family Centered Care, Learning modality