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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04995900
Recruitment Status : Recruiting
First Posted : August 9, 2021
Last Update Posted : March 15, 2023
Sponsor:
Collaborators:
National Heart Foundation, Australia
Department of Health, Victorian Government
Ambulance Victoria
Information provided by (Responsible Party):
Janet, Monash University

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Myocardial Infarction, Acute Other: Community education Not Applicable

Detailed Description:

Primary objectives:

To determine if targeted heart health education will:

  1. Increase ambulance use in ACS patients;
  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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2240 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes are collected blinded to the study allocation.
Primary Purpose: Prevention
Official Title: Heart Matters: A Stepped-wedge Cluster Randomized Controlled Trial of Heart Health Education Targeting Communities at High Risk of Acute Coronary Syndrome.
Actual Study Start Date : February 1, 2022
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
Intervention period with active Heart Matters education delivered
 Other: Community education
Heart Matters coordinators will deliver heart health education to the community using HM materials and Partner resources.
Other Name: Local campaign
No Intervention: Control
Control period with no Heart Matters education delivered.


Outcome Measures
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Primary Outcome Measures :
  1. Ambulance use for ACS [ Time Frame: 16 months ]
    The proportion of ACS patients that present to ED by ambulance.


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04995900


Contacts
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Contact: Janet Bray, PhD 0438866803 janet.bray@monash.edu
Contact: Natasha Dodge, MPH natasha.dodge@monash.edu

Locations
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Australia, Please Select
Victorian LGAs Recruiting
Melbourne, Please Select, Australia, 3004
Contact: Janet Bray       janet.bray@monash.edu   
Sponsors and Collaborators
Monash University
National Heart Foundation, Australia
Department of Health, Victorian Government
Ambulance Victoria
More Information
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Responsible Party: Janet, Associate Professor, Monash University
ClinicalTrials.gov Identifier: NCT04995900    
Other Study ID Numbers: 291276657
1180282 ( Other Grant/Funding Number: National Health and Medical Research Council (NHMRC) )
First Posted: August 9, 2021    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to data is restricted and is not available for sharing at the individual patient level.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Syndrome
Infarction
Disease
Pathologic Processes
 Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases