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OpenTrials
Completed

NCT Number: NCT04995900

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Victorian LGAs

Melbourne, Please Select, 3004, Australia

About this study

Primary objectives:

To determine if targeted heart health education will:

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

Secondary objectives

  • To determine if targeted heart health education:
  • Reduces the incidence of out-of-hospital cardiac arrest;
  • Improves survival in OHCA patients;
  • Improves survival in ACS patients;
  • Improves survival and ACS patients;
  • Increases presentations to ED for ACS and unspecified chest pain; and
  • Increases the rates of calls to ambulance for chest pain and non-chest pain.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult residents of the eight local government areas -

Exclusion criteria

Adults not residing in the eight local government areas.

-

Treatment and study plan

Community education

Other

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

Other names: Local campaign

Primary outcomes

  1. Ambulance use for ACS

    Time frame: 16 months

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

Secondary outcomes

  1. Median ACS patient delay time

    Time frame: 16 months

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

  2. ACS patient delay time <60 minutes

    Time frame: 16 months

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

  3. Median ACS patient prehospital delay time

    Time frame: 16 months

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

  4. ACS patients prehospital delay times <120 minutes

    Time frame: 16 months

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

  5. Awareness of own risk of heart attack

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

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

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

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

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

  7. Awareness of heart attack risk factors

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

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

  8. Number of correctly named heart attack risk factors

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

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

  9. Awareness of heart attack signs and symptoms

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

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

  10. Number of correctly named heart attack signs and symptoms

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

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

  11. Confidence in knowing how to act

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

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

  12. Ambulance use in scenarios

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

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

  13. Rates of Heart Health Checks

    Time frame: 16 months

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

  14. Rates of ACS ED presentations

    Time frame: 16 months

    The rates of ED presentations that are ACS

  15. Rates of unspecified chest pain ED presentations

    Time frame: 16 months

    Rates of ED presentations that are unspecified chest pain

  16. ACS ED presentations via GPs

    Time frame: 16 months

    Proportion of ACS ED presentations via General Practitioners

  17. Rates of ACS survival

    Time frame: 16 months

    The proportion of ACS patients surviving to hospital discharge

  18. Incidence of OHCA

    Time frame: 16 months

    incidence of out-of-hospital cardiac arrest

  19. Rates of OHCA

    Time frame: 16 months

    Rates out-of-hospital cardiac arrest survival

  20. Calls to ambulance for chest pain

    Time frame: 16 months

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

  21. Calls to ambulance for non- chest pain

    Time frame: 16 months

    Proportion of non-chest pain emergency calls to ambulance

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

  • Ambulance Victoria
  • Department of Health, Victorian Government
  • National Heart Foundation, Australia

Registry information

Official study title

Heart Matters: A Stepped-wedge Cluster Randomized Controlled Trial of Heart Health Education Targeting Communities at High Risk of Acute Coronary Syndrome.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2021
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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