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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04995900
Registration number
NCT04995900
Ethics application status
Date submitted
30/07/2021
Date registered
9/08/2021
Titles & IDs
Public title
Heart Matters: The Effectiveness of Heart Health Education in Regions at Highest-risk.
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Scientific title
Heart Matters: A Stepped-wedge Cluster Randomized Controlled Trial of Heart Health Education Targeting Communities at High Risk of Acute Coronary Syndrome.
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Secondary ID [1]
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1180282
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Secondary ID [2]
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291276657
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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:
Acute Coronary Syndrome
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Myocardial Infarction, Acute
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Community education
Experimental: Intervention - Intervention period with active Heart Matters education delivered
No intervention: Control - Control period with no Heart Matters education delivered.
Other interventions: Community education
Heart Matters coordinators will deliver heart health education to the community using HM materials and Partner resources.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Ambulance use for ACS
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Assessment method [1]
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The proportion of ACS patients that present to ED by ambulance.
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Timepoint [1]
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16 months
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Secondary outcome [1]
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Median ACS patient delay time
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Assessment method [1]
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The median ACS patients delay time (time from symptom onset to decision to seek medical attention).
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Timepoint [1]
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16 months
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Secondary outcome [2]
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ACS patient delay time <60 minutes
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Assessment method [2]
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The proportion of ACS patients with patient delay times \<60 minutes
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Timepoint [2]
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16 months
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Secondary outcome [3]
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Median ACS patient prehospital delay time
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Assessment method [3]
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The median ACS patient prehospital delay time (time from symptom onset to arrival at hospital).
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Timepoint [3]
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16 months
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Secondary outcome [4]
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ACS patients prehospital delay times <120 minutes
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Assessment method [4]
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The proportion of ACS patients with prehospital delay times \<120 minutes
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Timepoint [4]
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16 months
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Secondary outcome [5]
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Awareness of own risk of heart attack
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Assessment method [5]
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The proportion of adult members of the community who are aware of their own risk of heart attack.
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Timepoint [5]
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0-2 months and 6-8 months
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Secondary outcome [6]
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Awareness of heart attack as a leading cause of death
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Assessment method [6]
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The proportion of adult members of the community who identify heart disease a leading cause of death
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Timepoint [6]
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0-2 months and 6-8 months
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Secondary outcome [7]
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Awareness of heart attack risk factors
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Assessment method [7]
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The proportion of adult members of the community who identify cardiovascular risk factors
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Timepoint [7]
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0-2 months and 6-8 months
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Secondary outcome [8]
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Number of correctly named heart attack risk factors
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Assessment method [8]
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The number of correctly named cardiovascular risk factors by adult members of the community
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Timepoint [8]
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0-2 months and 6-8 months
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Secondary outcome [9]
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Awareness of heart attack signs and symptoms
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Assessment method [9]
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The proportion of adult members of the community aware of heart attack symptoms
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Timepoint [9]
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0-2 months and 6-8 months
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Secondary outcome [10]
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Number of correctly named heart attack signs and symptoms
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Assessment method [10]
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The number of correctly named ACS symptoms by adult members of the community
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Timepoint [10]
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0-2 months and 6-8 months
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Secondary outcome [11]
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Confidence in knowing how to act
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Assessment method [11]
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The proportion adult members of the community who are confident about what they would do if experiencing a heart attack
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Timepoint [11]
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0-2 months and 6-8 months
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Secondary outcome [12]
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Ambulance use in scenarios
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Assessment method [12]
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The proportion adult members of the community who correctly state they would call an ambulance for two heart attack scenarios.
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Timepoint [12]
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0-2 months and 6-8 months
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Secondary outcome [13]
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Rates of Heart Health Checks
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Assessment method [13]
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Rates of Medicare claims for General Practitioner (GP) Heart Health Checks
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Timepoint [13]
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16 months
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Secondary outcome [14]
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Rates of ACS ED presentations
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Assessment method [14]
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The rates of ED presentations that are ACS
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Timepoint [14]
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16 months
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Secondary outcome [15]
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Rates of unspecified chest pain ED presentations
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Assessment method [15]
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Rates of ED presentations that are unspecified chest pain
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Timepoint [15]
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16 months
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Secondary outcome [16]
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ACS ED presentations via GPs
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Assessment method [16]
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Proportion of ACS ED presentations via General Practitioners
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Timepoint [16]
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16 months
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Secondary outcome [17]
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Rates of ACS survival
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Assessment method [17]
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The proportion of ACS patients surviving to hospital discharge
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Timepoint [17]
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16 months
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Secondary outcome [18]
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Incidence of OHCA
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Assessment method [18]
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incidence of out-of-hospital cardiac arrest
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Timepoint [18]
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16 months
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Secondary outcome [19]
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Rates of OHCA
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Assessment method [19]
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Rates out-of-hospital cardiac arrest survival
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Timepoint [19]
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16 months
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Secondary outcome [20]
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Calls to ambulance for chest pain
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Assessment method [20]
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Proportion of chest pain (event type 10) calls to ambulance
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Timepoint [20]
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16 months
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Secondary outcome [21]
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Calls to ambulance for non- chest pain
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Assessment method [21]
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Proportion of non-chest pain emergency calls to ambulance
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Timepoint [21]
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16 months
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Eligibility
Key inclusion criteria
Adult residents of the eight local government areas -
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Minimum age
18
Years
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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?
No
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Key exclusion criteria
Adults not residing in the eight local government areas.
-
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled 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
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Crossover
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/03/2023
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Sample size
Target
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Accrual to date
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Final
2240
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Recruitment in Australia
Recruitment state(s)
Please Selec
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Recruitment hospital [1]
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Victorian LGAs - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Heart Foundation, Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Department of Health, Victorian Government
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Address [2]
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Country [2]
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Other collaborator category [3]
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Government body
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Name [3]
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Ambulance Victoria
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of the study is to evaluate whether providing a targeted heart health education campaign to regions at high risk of heart attacks will improve ACS patient's symptom recognition and response. The intervention will be will be evaluated according to a cluster randomized, stepped wedged design. The clusters are eight local government areas (LGAs) in Victoria, Australia. The main primary outcome will be assessed in consecutive patients presenting to emergency departments from the six LGAs throughout the study period with an ED diagnoses of acute coronary syndrome.
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Trial website
https://clinicaltrials.gov/study/NCT04995900
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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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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Access to data is restricted and is not available for sharing at the individual patient level.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04995900