Dependency on Medications Prescribed for Patient Clinical Trial
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
| Verified date | April 2013 |
| Source | University of Calgary |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Conjoint Health Research Ethics Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 61 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 17 Years |
| Eligibility |
Inclusion Criteria - Clinical diagnosis of Seizure disorder - Dependence on a anti-seizure medication Exclusion Criteria - No dependence on rescue medication |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| Canada | Alberta Children's Hospital | Calgary | Alberta |
| Lead Sponsor | Collaborator |
|---|---|
| University of Calgary |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | 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 | No |