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
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
Secondary ID [1] 313476 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiac arrest 335885 0
Condition category
Condition code
Emergency medicine 332471 332471 0 0
Resuscitation
Public Health 332589 332589 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 330052 0
Behaviour
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340010 0
Self Efficacy of participants in CPR
Assessment method [1] 340010 0
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)
Timepoint [1] 340010 0
Pre CPR training delivery (immediately before training) and post CPR training skills assessment (within 1 week of training session)
Secondary outcome [1] 442330 0
Acceptability of the CPR lesson plan
Assessment method [1] 442330 0
Theoretical Framework for acceptability Questionnaire (completed by teachers only)
Timepoint [1] 442330 0
Post CPR training (within 1 week of training session)
Secondary outcome [2] 442329 0
Effectiveness of Teacher led CPR training on student skills
Assessment method [2] 442329 0
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)
Timepoint [2] 442329 0
Post CPR training (within 1 week of training session)

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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
1/07/2026
Actual
Date of last data collection
Anticipated
8/07/2026
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317917 0
Charities/Societies/Foundations
Name [1] 317917 0
HMRI - Jack Murphy Memorial Society
Country [1] 317917 0
Australia
Primary sponsor type
Individual
Name
Jeremy Pallas - John Hunter Hospital
Country
Australia
Secondary sponsor category [1] 320262 0
None
Name [1] 320262 0
Country [1] 320262 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316602 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 316602 0
Ethics committee country [1] 316602 0
Australia
Date submitted for ethics approval [1] 316602 0
28/11/2024
Approval date [1] 316602 0
Ethics approval number [1] 316602 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 138382 0
Mr Jeremy Pallas
Address 138382 0
John Hunter Emergency Department, John Hunter Hospital, Lookout Road, New Lambton, NSW, 2305
Country 138382 0
Australia
Phone 138382 0
+61 432035171
Email 138382 0
jeremy.pallas@health.nsw.gov.au
Contact person for public queries
Name 138383 0
Jeremy Pallas
Address 138383 0
John Hunter Emergency Department, John Hunter Hospital, Lookout Road, New Lambton, NSW, 2305
Country 138383 0
Australia
Phone 138383 0
+61 432035171
Email 138383 0
jeremy.pallas@health.nsw.gov.au
Contact person for scientific queries
Name 138384 0
Jeremy Pallas
Address 138384 0
John Hunter Emergency Department, John Hunter Hospital, Lookout Road, New Lambton, NSW, 2305
Country 138384 0
Australia
Phone 138384 0
+61 432035171
Email 138384 0
jeremy.pallas@health.nsw.gov.au

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?
• De-identified individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• 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 (Jeremy.pallas@health.nsw.gov.au)

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.