Back to resultsA Simulation-based Intervention for Caregivers of Children With Seizures
Primary Purpose
Dependency on Medications Prescribed for Patient, Types of Seizures and Epileptic Syndromes
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Simulation
Sponsored by
About this trial
This is an interventional health services research trial for Dependency on Medications Prescribed for Patient focused on measuring Seizure, Caregivers, Family Centered Care, Learning modality
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of Seizure disorder
- Dependence on a anti-seizure medication
Exclusion Criteria
- No dependence on rescue medication
Sites / Locations
- Alberta Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1
2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01831063
Brief Title
A Simulation-based Intervention for Caregivers of Children With Seizures
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dependency on Medications Prescribed for Patient, Types of Seizures and Epileptic Syndromes
Keywords
Seizure, Caregivers, Family Centered Care, Learning modality
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Simulation
Intervention Description
The experimental group received a simulation based seizure teaching session in addition to the traditional seizure teaching
Primary Outcome Measure Information:
Title
KidSIM Emergent Seizure Management Checklist
Description
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.
Time Frame
Baseline, 48 hours and 6 months
Secondary Outcome Measure Information:
Title
The Aspire KidSIM Parent Seizure Self-efficacy Questionnaire
Description
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.
Time Frame
Baseline , 48 hours and 6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Clinical diagnosis of Seizure disorder
Dependence on a anti-seizure medication
Exclusion Criteria
No dependence on rescue medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Sigalet, PhD
Organizational Affiliation
Alberta Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent Grant, MD
Organizational Affiliation
Alberta Children's Hospital, University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam Cheng, MD
Organizational Affiliation
Alberta Children's Hospital, University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B6A8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Simulation-based Intervention for Caregivers of Children With Seizures
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