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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12625000002482p
Ethics application status
Submitted, not yet approved
Date submitted
27/11/2024
Date registered
7/01/2025
Date last updated
7/01/2025
Date data sharing statement initially provided
7/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
The ‘TEACH’ (Teacher Enabled Autonomous Cardiopulmonary Resuscitation (CPR) training in High schools) Study
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Scientific title
The ‘TEACH’ (Teacher Enabled Autonomous CPR training in High schools) Study - Assessing the effectiveness of a Video based Cardiopulmonary Resuscitation (CPR) lesson plan delivered by Australian High School Teachers in promoting CPR self-efficacy in high school students
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Secondary ID [1]
313476
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
cardiac arrest
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Condition category
Condition code
Emergency medicine
332471
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0
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Resuscitation
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Public Health
332589
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The study aims to examine the effectiveness of a video-based CPR lesson plan to aid in classroom CPR training delivered by existing school teachers in the Australian High Schools with a particular focus on students’ self-efficacy and ability to perform compression only CPR.
What is involved for participants: a one off 45 minute face to face CPR teaching session in a normal classroom setting, delivered by their regular classroom teacher. This session will be taught being a web hosted interactive lesson plan consisting of 6 developed CPR training videos with pauses for practical classroom interaction.
This session will be followed within 1 week by a face to face CPR skill assessment delivered in a classroom environment by research staff. The CPR skill assessment will involve a brief simulation based scenario assessment marked against a critical item checklist developed for this trial. A pre and post intervention survey will also be delivered to students.
Teacher preparation: teachers delivering the intervention will be provided with face to face training on how to deliver the CPR training session within 4 weeks prior to the scheduled trial delivery. This training will be facilitated by the research staff responsible for developing the training resources. The anticipate duration of this training will be a single 90 minute session.
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Intervention code [1]
330052
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Behaviour
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Comparator / control treatment
None
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Self Efficacy of participants in CPR
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Assessment method [1]
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Pre and Post Interventions Surveys - based on the Basic Resuscitation Skills Self Efficacy Scale (BRS-SES) by Hernandez-Padilla et al with minor modifications to ensure its suitability for a group of non-healthcare providers learning compression only CPR (completed by students only)
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Timepoint [1]
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Pre CPR training delivery (immediately before training) and post CPR training skills assessment (within 1 week of training session)
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Secondary outcome [1]
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Acceptability of the CPR lesson plan
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Assessment method [1]
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Theoretical Framework for acceptability Questionnaire (completed by teachers only)
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Timepoint [1]
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Post CPR training (within 1 week of training session)
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Secondary outcome [2]
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Effectiveness of Teacher led CPR training on student skills
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Assessment method [2]
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Practical assessment using critical item checklist - This checklist has been developed for this study and includes standardised measures of CPR effectiveness. (completed by students only)
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Timepoint [2]
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Post CPR training (within 1 week of training session)
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Eligibility
Key inclusion criteria
Inclusion criteria. High schools will be included if they are:
1. Situated within the Hunter New England Local Health district catchment area;
2. Are independent/Catholic primary schools.
Individuals will be eligible to take part in the study if they are:
1. 7th – 12th grade students
2. Attending an eligible high school in the greater Newcastle area
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion criteria. Schools were excluded if they:
- had already provided CPR training in the last 12 months to their students;
- catered for both elementary and secondary students; or
- were exclusively for children requiring specialist care.
Students will not be eligible to participate in the study if they have:
- Any physical limitations that would prevent them performing chest compressions.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2025
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Actual
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Date of last participant enrolment
Anticipated
1/07/2026
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Actual
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Date of last data collection
Anticipated
8/07/2026
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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HMRI - Jack Murphy Memorial Society
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Jeremy Pallas - John Hunter Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
320262
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Country [1]
320262
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Hunter New England Human Research Ethics Committee
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Ethics committee address [1]
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https://www.hnehealth.nsw.gov.au/research-office/research_ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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28/11/2024
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Approval date [1]
316602
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Ethics approval number [1]
316602
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Summary
Brief summary
The study aims to examine the effectiveness of a video-based CPR lesson plan to aid in classroom CPR video-based training delivered by existing school teachers in the Australian High Schools with a particular focus on students’ self-efficacy and ability to perform compression only CPR. The study will function as a pilot to establish the feasibility of classroom CPR training delivered by existing school teachers in the Australian High Schools. The study uses a prospective, non-randomised cohort design. It is hypothesised that the proposed video based lesson plan will be an effective and acceptable method of teaching school aged children CPR in an Australian practice context.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Jeremy Pallas
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Address
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John Hunter Emergency Department, John Hunter Hospital, Lookout Road, New Lambton, NSW, 2305
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Country
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Australia
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Phone
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+61 432035171
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Jeremy Pallas
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Address
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John Hunter Emergency Department, John Hunter Hospital, Lookout Road, New Lambton, NSW, 2305
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Country
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Australia
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Phone
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+61 432035171
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Jeremy Pallas
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Address
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John Hunter Emergency Department, John Hunter Hospital, Lookout Road, New Lambton, NSW, 2305
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Country
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Australia
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Phone
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+61 432035171
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Decisions to shared de-identified individual patient data underlying published results will be made on a case-by-case basis at the discretion of Primary Sponsor
Conditions for requesting access:
•
-
What individual participant data might be shared?
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De-identified individual participant data underlying published results only
What types of analyses could be done with individual participant data?
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IPD will only be shared only to achieve the aims in the approved proposal
When can requests for individual participant data be made (start and end dates)?
From:
Beginning 3 months and ending 5 years following main results publication
To:
-
Where can requests to access individual participant data be made, or data be obtained directly?
•
Access subject to approvals by Principal Investigator (
[email protected]
)
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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