Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000284460
Ethics application status
Approved
Date submitted
31/03/2025
Date registered
11/04/2025
Date last updated
11/05/2025
Date data sharing statement initially provided
11/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Masters Football and Cardiovascular Risk Reduction Study: The impact of an educational program on cardiac health awareness in amateur football players aged 35 years and over.
Scientific title
Masters Football and Cardiovascular Risk Reduction Study: The impact of an educational program on cardiac health awareness in amateur football players aged 35 years and over.
Secondary ID [1] 313730 0
None
Universal Trial Number (UTN)
Trial acronym
MAFACARI II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular 336337 0
Condition category
Condition code
Cardiovascular 332872 332872 0 0
Coronary heart disease
Public Health 332873 332873 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be an educational program to improve cardiac health awareness.

At the commencement of the study, all participants will be asked to complete an online self-administered questionnaire. The questionnaire will take approximately 15-20 minutes to complete.

Participants will then be randomly allocated to one of two groups, the intervention group (Group A) or the control group (Group B).

The intervention group (half of the participants) will be asked to access and complete an online educational program (the study intervention). The program can be completed at their own pace, and all up should take between 45 mins – 60 mins to complete. Participants can access the content at any time, from a location and at a time convenient to them. They will be prompted to review the program on a second occasion one month later.

The educational program will incorporate 5 key video-based modules:
(i) Heart Disease basics, terminology and risk factors
(ii) Symptom recognition and response - knowledge, attitudes, beliefs of myocardial infarction (MI), and of warning symptoms
(iii) Instruction on CPR, and Defibrillator use and access
(iv) Case scenarios – learning from case stories of players with heart disease
(v) Understanding of cardiac testing – a discussion of which tests are available

The video-based modules include educational video lectures, along with written content and short quizzes to reinforce the content within each module. Each module should take participants around 8-12 minutes to complete.

The educational program has been developed specifically for the this study, with lessons incorporating content from known guidelines and sources including The National Heart Foundation of Australia and The Victor Chang Cardiac Research Institute.

Adherence to the intervention (completion of the online educational program) will be recorded and monitored within the Kajabi platform. Kajabi Website Analytics will be used to track individual learner progress, enabling the Study Coordinator to monitor participant progress in individual lessons and modules, overall completion of course (as a percentage score of total number of lessons), number of logins, start date and last activity date.

If a participant in Group A has not commenced the educational program within two weeks of enrolment, a reminder using their preferred contact method (text or email) will be sent.

If a participant in Group A has not completed the educational program within one month of enrolment, a reminder using their preferred contact method (text or email) will be sent.

If, after prompting, they don’t complete the educational program, we will note this in our results.
Intervention code [1] 330755 0
Behaviour
Intervention code [2] 330754 0
Prevention
Comparator / control treatment
The control group will be directed to go about their normal business and receive no intervention.
Control group
Active

Outcomes
Primary outcome [1] 340397 0
The primary endpoint will be the impact of the educational program on cardiac awareness.
Timepoint [1] 340397 0
1. ACS Response Index (knowledge, attitudes and beliefs subscales) measured at baseline and two months post-enrolment. 2. Early warning symptom knowledge and response (familiarity with angina and duration of possible warning symptoms before a heart attack) measured at baseline and two months post-enrolment. 3. Knowledge of available tests (coronary calcium score, stress echocardiogram, CT-coronary angiogram, chest x-ray) measured at baseline and two months post-enrolment. 4. Familiarity with CPR and Defibrillation measured at baseline and two months post-enrolment. 5. Appropriate response to a hypothetical case of chest pain while playing measured at baseline and two months post-enrolment.
Secondary outcome [1] 446163 0
ACS Response Index beliefs subscale score
Timepoint [1] 446163 0
ACS Response Index beliefs subscale measured at baseline and two months post-enrolment.
Secondary outcome [2] 445922 0
Early warning symptom knowledge and response (familiarity with angina and duration of possible warning symptoms before a heart attack) assessed as a composite outcome.
Timepoint [2] 445922 0
Early warning symptom knowledge and response (familiarity with angina and duration of possible warning symptoms before a heart attack) measured at baseline and two months post-enrolment.
Secondary outcome [3] 445925 0
Appropriate response to a hypothetical case of chest pain while playing.
Timepoint [3] 445925 0
Appropriate response to a hypothetical case of chest pain while playing measured at baseline and two months post-enrolment.
Secondary outcome [4] 446159 0
ACS Response Index knowledge subscale score
Timepoint [4] 446159 0
ACS Response Index knowledge subscale measured at baseline and two months post-enrolment.
Secondary outcome [5] 445948 0
Familiarity with cardiovascular risk factors, terminology and outcomes assessed as a composite outcome.
Timepoint [5] 445948 0
Familiarity with cardiovascular risk factors, terminology and outcomes measured at baseline and two months post-enrolment.
Secondary outcome [6] 445924 0
Familiarity with CPR and Defibrillation assessed as a composite outcome.
Timepoint [6] 445924 0
Familiarity with CPR and Defibrillation measured at baseline and two months post-enrolment.
Secondary outcome [7] 446160 0
ACS Response Index attitudes subscale score
Timepoint [7] 446160 0
ACS Response Index attitudes subscale measured at baseline and two months post-enrolment.
Secondary outcome [8] 443949 0
ACS Response Index (knowledge, attitudes and beliefs subscales) assessed as a composite outcome.
Timepoint [8] 443949 0
ACS Response Index (knowledge, attitudes and beliefs subscales) measured at baseline and two months post-enrolment.
Secondary outcome [9] 445923 0
Knowledge of available tests (coronary calcium score, stress echocardiogram, CT-coronary angiogram, chest x-ray) assessed as a composite outcome.
Timepoint [9] 445923 0
Knowledge of available tests (coronary calcium score, stress echocardiogram, CT-coronary angiogram, chest x-ray) measured at baseline and two months post-enrolment.

Eligibility
Key inclusion criteria
Participants will be female and male Masters age (>= 35 years) amateur football players competing at A grade, B grade or lower competition, and social games.
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation according to randomisation list
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence list generated by independent Investigator not involved in participant recruitment or follow up using GraphPad Prism randomisation software to allocate participant numbers into two groups (Group A and Group B) in a 1:1 ratio
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/04/2025
Actual
27/04/2025
Date of last participant enrolment
Anticipated
1/11/2025
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
120
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 43607 0
2065 - Royal North Shore Hospital

Funding & Sponsors
Funding source category [1] 318197 0
Charities/Societies/Foundations
Name [1] 318197 0
Heart Research Australia
Country [1] 318197 0
Australia
Primary sponsor type
Hospital
Name
Northern Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 320584 0
None
Name [1] 320584 0
Address [1] 320584 0
Country [1] 320584 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316848 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 316848 0
Ethics committee country [1] 316848 0
Australia
Date submitted for ethics approval [1] 316848 0
08/11/2024
Approval date [1] 316848 0
27/11/2024
Ethics approval number [1] 316848 0
2024/ETH01988

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139190 0
Prof Geoffrey Tofler
Address 139190 0
Cardiology Department, Level 5A, ASB Royal North Shore Hospital, Reserve Rd St. Leonards, NSW 2065
Country 139190 0
Australia
Phone 139190 0
+61 2 9463 1514
Fax 139190 0
Email 139190 0
[email protected]
Contact person for public queries
Name 139191 0
Geoffrey Tofler
Address 139191 0
Cardiology Department, Level 5A, ASB Royal North Shore Hospital, Reserve Rd St. Leonards, NSW 2065
Country 139191 0
Australia
Phone 139191 0
+61 2 9463 1514
Fax 139191 0
Email 139191 0
[email protected]
Contact person for scientific queries
Name 139192 0
Geoffrey Tofler
Address 139192 0
Cardiology Department, Level 5A, ASB Royal North Shore Hospital, Reserve Rd St. Leonards, NSW 2065
Country 139192 0
Australia
Phone 139192 0
+61 2 9463 1514
Fax 139192 0
Email 139192 0
[email protected]

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:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Postal address: Cardiology Department, Level 5A, ASB Royal North Shore Hospital, Reserve Rd St. Leonards, NSW 2065

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.