Dependency on Medications Prescribed for PatientNCT01831063
A Simulation-based Intervention for Caregivers of Children With Seizures
A study testing Simulation in people with Dependency on Medications Prescribed for Patient and Types of Seizures and Epileptic Syndromes, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Dependency on Medications Prescribed for Patient, Types of Seizures and Epileptic Syndromes
- What is being tested?
- Simulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of Seizure disorder
- Dependence on a anti-seizure medication
Who cannot join
- No dependence on rescue medication
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Simulation
- Keywords
- Seizure, Caregivers, Family Centered Care, Learning modality
- Medical subject headings
- Epileptic Syndromes, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimulationBehavioural
The experimental group received a simulation based seizure teaching session in addition to the traditional seizure teaching
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 48 hours and 6 months
Secondary outcomes (1)
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.
Measured: Baseline , 48 hours and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startOct 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dependency on Medications Prescribed for PatientStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Cheng, University of Calgary
- Investigators
- Elaine Sigalet, PhD, Principal investigator, Alberta Children's HospitalVincent Grant, MD, Principal investigator, Alberta Children's Hospital, University of CalgaryAdam Cheng, MD, Principal investigator, Alberta Children's Hospital, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831063
- Sponsor's protocol ID
- Alberta Children's Hospital
- Status last verified
- Apr 2013
- First submitted
- 1 Apr 2013
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01831063
- Acronym / sponsor ID
- Alberta Children's Hospital
- Conditions
- Dependency on Medications Prescribed for Patient, Types of Seizures and Epileptic Syndromes
- Keywords
- Seizure, Caregivers, Family Centered Care, Learning modality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: SimulationThis 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical diagnosis of Seizure disorder
- Dependence on a anti-seizure medication
Key exclusion criteria (1 listed)
- No dependence on rescue medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimulationThe experimental group received a simulation based seizure teaching session in addition to the traditional seizure teaching | Behavioural | 2 |
Primary outcome
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.
1 secondary outcome
The Aspire KidSIM Parent Seizure Self-efficacy Questionnaire
Time frame: Baseline , 48 hours and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Sigalet, PhD principal investigator
Alberta Children's Hospital
Vincent Grant, MD principal investigator
Alberta Children's Hospital, University of Calgary
Adam Cheng, MD principal investigator
Alberta Children's Hospital, University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation in people with Dependency on Medications Prescribed for Patient and Types of Seizures and Epileptic Syndromes, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KidSIM Emergent Seizure Management Checklist (time frame: Baseline, 48 hours and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2013.