Ignite Creation Date:
2024-05-06 @ 1:08 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03948633
Status:
UNKNOWN
Last Update Posted:
2019-05-28
First Post:
2019-04-24
Brief Title:
Feasibility of Implementation of CARD for School-Based Immunizations
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
Improving the Vaccination Experience at School in Calgary
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A multi-faceted knowledge translation intervention - The CARD C-Comfort A-Ask R-Relax D-Distract System - was developed to improve the vaccination experience of students at school CARD is a framework for delivering vaccinations that is student-centred that promotes coping This study will examine the feasibility of CARD implementation procedures and measures in the school vaccination program in Calgary Alberta for use in a larger cluster trial
Detailed Description:
Vaccination is estimated to have saved more lives in Canada over the last 50 years than any other single intervention and is considered one of the most important advances in the prevention of disease One major drawback of vaccination however is that the usual route of administration involves a painful needle injection In students undergoing school-based mass vaccinations vaccine injections frequently cause sever distress and fainting with some serious injuries resulting from fainting Concerns about pain andor needle fear are also directly responsible for vaccine refusal in this population
An evidence based clinical practice guideline for mitigating vaccine injection pain fear and fainting has been developed however it is not yet implemented across different school-based vaccination settings and students are not benefiting from the research evidence In a prior small-scale project investigators developed and implemented a multi-faceted knowledge translation intervention - The CARD C-Comfort A-Ask R-Relax D-Distract System - in some schools in a small public health region in Niagara Ontario CARD is a framework for delivering vaccinations that is student-centred and promotes coping It integrates recommendations from the guideline in two separate components of the vaccination delivery program 1 pre-vaccination day preparation and 2 vaccination day activities Investigators found preliminary evidence of acceptability appropriateness satisfaction and clinical effectiveness of CARD when used in grade 7 students in Niagara
In this study investigators plan to determine the feasibility of implementing CARD in a diverse and more complex public health region in Calgary Alberta Specifically investigators will determine recruitment rates adherence to CARD protocol response rates for questionnaires acceptability appropriateness fit and satisfaction The results will inform a future cluster trial
An evidence based clinical practice guideline for mitigating vaccine injection pain fear and fainting has been developed however it is not yet implemented across different school-based vaccination settings and students are not benefiting from the research evidence In a prior small-scale project investigators developed and implemented a multi-faceted knowledge translation intervention - The CARD C-Comfort A-Ask R-Relax D-Distract System - in some schools in a small public health region in Niagara Ontario CARD is a framework for delivering vaccinations that is student-centred and promotes coping It integrates recommendations from the guideline in two separate components of the vaccination delivery program 1 pre-vaccination day preparation and 2 vaccination day activities Investigators found preliminary evidence of acceptability appropriateness satisfaction and clinical effectiveness of CARD when used in grade 7 students in Niagara
In this study investigators plan to determine the feasibility of implementing CARD in a diverse and more complex public health region in Calgary Alberta Specifically investigators will determine recruitment rates adherence to CARD protocol response rates for questionnaires acceptability appropriateness fit and satisfaction The results will inform a future cluster trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None