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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04995900




Registration number
NCT04995900
Ethics application status
Date submitted
30/07/2021
Date registered
9/08/2021
Date last updated
15/06/2023

Titles & IDs
Public title
Heart Matters: The Effectiveness of Heart Health Education in Regions at Highest-risk.
Scientific title
Heart Matters: A Stepped-wedge Cluster Randomized Controlled Trial of Heart Health Education Targeting Communities at High Risk of Acute Coronary Syndrome.
Secondary ID [1] 0 0
1180282
Secondary ID [2] 0 0
291276657
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Myocardial Infarction, Acute 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ambulance use for ACS
Timepoint [1] 0 0
16 months
Secondary outcome [1] 0 0
Median ACS patient delay time
Timepoint [1] 0 0
16 months
Secondary outcome [2] 0 0
ACS patient delay time <60 minutes
Timepoint [2] 0 0
16 months
Secondary outcome [3] 0 0
Median ACS patient prehospital delay time
Timepoint [3] 0 0
16 months
Secondary outcome [4] 0 0
ACS patients prehospital delay times <120 minutes
Timepoint [4] 0 0
16 months
Secondary outcome [5] 0 0
Awareness of own risk of heart attack
Timepoint [5] 0 0
0-2 months and 6-8 months
Secondary outcome [6] 0 0
Awareness of heart attack as a leading cause of death
Timepoint [6] 0 0
0-2 months and 6-8 months
Secondary outcome [7] 0 0
Awareness of heart attack risk factors
Timepoint [7] 0 0
0-2 months and 6-8 months
Secondary outcome [8] 0 0
Number of correctly named heart attack risk factors
Timepoint [8] 0 0
0-2 months and 6-8 months
Secondary outcome [9] 0 0
Awareness of heart attack signs and symptoms
Timepoint [9] 0 0
0-2 months and 6-8 months
Secondary outcome [10] 0 0
Number of correctly named heart attack signs and symptoms
Timepoint [10] 0 0
0-2 months and 6-8 months
Secondary outcome [11] 0 0
Confidence in knowing how to act
Timepoint [11] 0 0
0-2 months and 6-8 months
Secondary outcome [12] 0 0
Ambulance use in scenarios
Timepoint [12] 0 0
0-2 months and 6-8 months
Secondary outcome [13] 0 0
Rates of Heart Health Checks
Timepoint [13] 0 0
16 months
Secondary outcome [14] 0 0
Rates of ACS ED presentations
Timepoint [14] 0 0
16 months
Secondary outcome [15] 0 0
Rates of unspecified chest pain ED presentations
Timepoint [15] 0 0
16 months
Secondary outcome [16] 0 0
ACS ED presentations via GPs
Timepoint [16] 0 0
16 months
Secondary outcome [17] 0 0
Rates of ACS survival
Timepoint [17] 0 0
16 months
Secondary outcome [18] 0 0
Incidence of OHCA
Timepoint [18] 0 0
16 months
Secondary outcome [19] 0 0
Rates of OHCA
Timepoint [19] 0 0
16 months
Secondary outcome [20] 0 0
Calls to ambulance for chest pain
Timepoint [20] 0 0
16 months
Secondary outcome [21] 0 0
Calls to ambulance for non- chest pain
Timepoint [21] 0 0
16 months

Eligibility
Key inclusion criteria
Adult residents of the eight local government areas -
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adults not residing in the eight local government areas.

-

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2023
Sample size
Target
Accrual to date
Final
2240
Recruitment in Australia
Recruitment state(s)
Please Selec
Recruitment hospital [1] 0 0
Victorian LGAs - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Heart Foundation, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Department of Health, Victorian Government
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Ambulance Victoria
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04995900
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries