CClinicalTrials.gg
CompletedNCT04995900Updated Jun 15, 2023

Heart Matters: The Effectiveness of Heart Health Education in Regions at Highest-risk.

An interventional study of Community education in Acute Coronary Syndrome and Myocardial Infarction, Acute, sponsored by Monash University. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-15.

Sponsored by Monash University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
2,240
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Primary objectives:

To determine if targeted heart health education will:

  1. Increase ambulance use in ACS patients (main primary outcome);
  2. Decrease patient and prehospital delay times in ACS patients;
  3. Increase awareness of personal cardiovascular risk and associated factors in adult community members; and
  4. Increase cardiovascular knowledge and confidence to act to heart attack warning signs in adult community members.

Secondary objectives

  1. To determine if targeted heart health education:
  2. Reduces the incidence of out-of-hospital cardiac arrest;
  3. Improves survival in OHCA patients;
  4. Improves survival in ACS patients;
  5. Improves survival and ACS patients;
  6. Increases presentations to ED for ACS and unspecified chest pain; and
  7. Increases the rates of calls to ambulance for chest pain and non-chest pain.
  8. Increases the rate of Heart Health Checks.

Intervention: To meet the objectives of the study, we will employ HM coordinators for each of the eight high-risk LGAs to organise and deliver our HM education program using HM materials and Partner resources.

Design: The stepped-wedge design is a uni-directional cross-over design - where the randomisation element is when the cluster crosses-over to the intervention following a control period.

Over the 16-month study period, the eight LGAs will move into the intervention phase at two month intervals. As four LGAs are in close proximity, these LGAs will switch from control to intervention periods at the same time to avoid possible contamination.

02

Conditions studied

  • Acute Coronary Syndrome
  • Myocardial Infarction, Acute
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 2,240 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Monash University is the lead sponsor of 81 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: Adult residents of the eight local government areas -

Exclusion Criteria: Adults not residing in the eight local government areas.

-

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
2,240 participants (actual)

Study arms

  • Experimental
    Intervention

    Intervention period with active Heart Matters education delivered

    Other: Community education

  • No intervention
    Control

    Control period with no Heart Matters education delivered.

Interventions

  • OtherCommunity education

    Heart Matters coordinators will deliver heart health education to the community using HM materials and Partner resources.

    Also known as: Local campaign

06

What researchers measure

Primary outcomes

  1. Ambulance use for ACS

    The proportion of ACS patients that present to ED by ambulance.

    Time frame: 16 months

Secondary outcomes

  1. Median ACS patient delay time

    The median ACS patients delay time (time from symptom onset to decision to seek medical attention).

    Time frame: 16 months

  2. ACS patient delay time <60 minutes

    The proportion of ACS patients with patient delay times \<60 minutes

    Time frame: 16 months

  3. Median ACS patient prehospital delay time

    The median ACS patient prehospital delay time (time from symptom onset to arrival at hospital).

    Time frame: 16 months

  4. ACS patients prehospital delay times <120 minutes

    The proportion of ACS patients with prehospital delay times \<120 minutes

    Time frame: 16 months

  5. Awareness of own risk of heart attack

    The proportion of adult members of the community who are aware of their own risk of heart attack.

    Time frame: 0-2 months and 6-8 months

  6. Awareness of heart attack as a leading cause of death

    The proportion of adult members of the community who identify heart disease a leading cause of death

    Time frame: 0-2 months and 6-8 months

  7. Awareness of heart attack risk factors

    The proportion of adult members of the community who identify cardiovascular risk factors

    Time frame: 0-2 months and 6-8 months

  8. Number of correctly named heart attack risk factors

    The number of correctly named cardiovascular risk factors by adult members of the community

    Time frame: 0-2 months and 6-8 months

  9. Awareness of heart attack signs and symptoms

    The proportion of adult members of the community aware of heart attack symptoms

    Time frame: 0-2 months and 6-8 months

  10. Number of correctly named heart attack signs and symptoms

    The number of correctly named ACS symptoms by adult members of the community

    Time frame: 0-2 months and 6-8 months

  11. Confidence in knowing how to act

    The proportion adult members of the community who are confident about what they would do if experiencing a heart attack

    Time frame: 0-2 months and 6-8 months

  12. Ambulance use in scenarios

    The proportion adult members of the community who correctly state they would call an ambulance for two heart attack scenarios.

    Time frame: 0-2 months and 6-8 months

  13. Rates of Heart Health Checks

    Rates of Medicare claims for General Practitioner (GP) Heart Health Checks

    Time frame: 16 months

  14. Rates of ACS ED presentations

    The rates of ED presentations that are ACS

    Time frame: 16 months

  15. Rates of unspecified chest pain ED presentations

    Rates of ED presentations that are unspecified chest pain

    Time frame: 16 months

  16. ACS ED presentations via GPs

    Proportion of ACS ED presentations via General Practitioners

    Time frame: 16 months

  17. Rates of ACS survival

    The proportion of ACS patients surviving to hospital discharge

    Time frame: 16 months

  18. Incidence of OHCA

    incidence of out-of-hospital cardiac arrest

    Time frame: 16 months

  19. Rates of OHCA

    Rates out-of-hospital cardiac arrest survival

    Time frame: 16 months

  20. Calls to ambulance for chest pain

    Proportion of chest pain (event type 10) calls to ambulance

    Time frame: 16 months

  21. Calls to ambulance for non- chest pain

    Proportion of non-chest pain emergency calls to ambulance

    Time frame: 16 months

07

Study locations

1 site
  • Victorian LGAs
    Melbourne, Please Select 3004, Australia
08

References and documents

Individual participant data

Plan to share: No — Access to data is restricted and is not available for sharing at the individual patient level.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04995900
Lead sponsor
Monash University
Collaborators
National Heart Foundation, Australia, Department of Health, Victorian Government, Ambulance Victoria
Responsible party
Janet (Associate Professor, Monash University) — Principal investigator
First posted
Aug 9, 2021
Start date
Feb 1, 2022
Primary completion
Mar 31, 2023
Completion
Mar 31, 2023
Last update
Jun 15, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion