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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.
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
Government body
Name [3] 0 0
Ambulance Victoria
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Access to data is restricted and is not available for sharing at the individual patient level.


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