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

Sponsor
Monash University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04995900
Collaborator
National Heart Foundation, Australia (Other), Department of Health, Victorian Government (Other), Ambulance Victoria (Other)
2,240
1
2
22.9
97.7

Study Details

Study Description

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
  • Other: Community education
N/A

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

Study Type:
Interventional
Anticipated 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.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 :
Feb 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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 Names:
  • Local campaign
  • No Intervention: Control

    Control period with no Heart Matters education delivered.

    Outcome Measures

    Primary Outcome Measures

    1. Ambulance use for ACS [16 months]

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

    Secondary Outcome Measures

    1. Median ACS patient delay time [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 [16 months]

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

    3. Median ACS patient prehospital delay time [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 [16 months]

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

    5. Awareness of own risk of heart attack [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 [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 [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 [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 [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 [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 [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 [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 [16 months]

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

    14. Rates of ACS ED presentations [16 months]

      The rates of ED presentations that are ACS

    15. Rates of unspecified chest pain ED presentations [16 months]

      Rates of ED presentations that are unspecified chest pain

    16. ACS ED presentations via GPs [16 months]

      Proportion of ACS ED presentations via General Practitioners

    17. Rates of ACS survival [16 months]

      The proportion of ACS patients surviving to hospital discharge

    18. Incidence of OHCA [16 months]

      incidence of out-of-hospital cardiac arrest

    19. Rates of OHCA [16 months]

      Rates out-of-hospital cardiac arrest survival

    20. Calls to ambulance for chest pain [16 months]

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

    21. Calls to ambulance for non- chest pain [16 months]

      Proportion of non-chest pain emergency calls to ambulance

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

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

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

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Victorian LGAs Melbourne Please Select Australia 3004

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janet, Associate Professor, Monash University
    ClinicalTrials.gov Identifier:
    NCT04995900
    Other Study ID Numbers:
    • 291276657
    • 1180282
    First Posted:
    Aug 9, 2021
    Last Update Posted:
    Feb 2, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 2, 2022