Heart Matters: The Effectiveness of Heart Health Education in Regions at Highest-risk.
Primary Purpose
Acute Coronary Syndrome, Myocardial Infarction, Acute
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Community education
Sponsored by
About this trial
This is an interventional prevention trial for Acute Coronary Syndrome
Eligibility Criteria
Inclusion Criteria: Adult residents of the eight local government areas -
Exclusion Criteria: Adults not residing in the eight local government areas.
-
Sites / Locations
- Victorian LGAs
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Intervention period with active Heart Matters education delivered
Control period with no Heart Matters education delivered.
Outcomes
Primary Outcome Measures
Ambulance use for ACS
The proportion of ACS patients that present to ED by ambulance.
Secondary Outcome Measures
Median ACS patient delay time
The median ACS patients delay time (time from symptom onset to decision to seek medical attention).
ACS patient delay time <60 minutes
The proportion of ACS patients with patient delay times <60 minutes
Median ACS patient prehospital delay time
The median ACS patient prehospital delay time (time from symptom onset to arrival at hospital).
ACS patients prehospital delay times <120 minutes
The proportion of ACS patients with prehospital delay times <120 minutes
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.
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
Awareness of heart attack risk factors
The proportion of adult members of the community who identify cardiovascular risk factors
Number of correctly named heart attack risk factors
The number of correctly named cardiovascular risk factors by adult members of the community
Awareness of heart attack signs and symptoms
The proportion of adult members of the community aware of heart attack symptoms
Number of correctly named heart attack signs and symptoms
The number of correctly named ACS symptoms by adult members of the community
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
Ambulance use in scenarios
The proportion adult members of the community who correctly state they would call an ambulance for two heart attack scenarios.
Rates of Heart Health Checks
Rates of Medicare claims for General Practitioner (GP) Heart Health Checks
Rates of ACS ED presentations
The rates of ED presentations that are ACS
Rates of unspecified chest pain ED presentations
Rates of ED presentations that are unspecified chest pain
ACS ED presentations via GPs
Proportion of ACS ED presentations via General Practitioners
Rates of ACS survival
The proportion of ACS patients surviving to hospital discharge
Incidence of OHCA
incidence of out-of-hospital cardiac arrest
Rates of OHCA
Rates out-of-hospital cardiac arrest survival
Calls to ambulance for chest pain
Proportion of chest pain (event type 10) calls to ambulance
Calls to ambulance for non- chest pain
Proportion of non-chest pain emergency calls to ambulance
Full Information
NCT ID
NCT04995900
First Posted
July 30, 2021
Last Updated
June 12, 2023
Sponsor
Monash University
Collaborators
National Heart Foundation, Australia, Department of Health, Victorian Government, Ambulance Victoria
1. Study Identification
Unique Protocol Identification Number
NCT04995900
Brief Title
Heart Matters: The Effectiveness of Heart Health Education in Regions at Highest-risk.
Official Title
Heart Matters: A Stepped-wedge Cluster Randomized Controlled Trial of Heart Health Education Targeting Communities at High Risk of Acute Coronary Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Monash University
Collaborators
National Heart Foundation, Australia, Department of Health, Victorian Government, Ambulance Victoria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Myocardial Infarction, Acute
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Outcomes Assessor
Masking Description
Outcomes are collected blinded to the study allocation.
Allocation
Randomized
Enrollment
2240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention period with active Heart Matters education delivered
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control period with no Heart Matters education delivered.
Intervention Type
Other
Intervention Name(s)
Community education
Other Intervention Name(s)
Local campaign
Intervention Description
Heart Matters coordinators will deliver heart health education to the community using HM materials and Partner resources.
Primary Outcome Measure Information:
Title
Ambulance use for ACS
Description
The proportion of ACS patients that present to ED by ambulance.
Time Frame
16 months
Secondary Outcome Measure Information:
Title
Median ACS patient delay time
Description
The median ACS patients delay time (time from symptom onset to decision to seek medical attention).
Time Frame
16 months
Title
ACS patient delay time <60 minutes
Description
The proportion of ACS patients with patient delay times <60 minutes
Time Frame
16 months
Title
Median ACS patient prehospital delay time
Description
The median ACS patient prehospital delay time (time from symptom onset to arrival at hospital).
Time Frame
16 months
Title
ACS patients prehospital delay times <120 minutes
Description
The proportion of ACS patients with prehospital delay times <120 minutes
Time Frame
16 months
Title
Awareness of own risk of heart attack
Description
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
Title
Awareness of heart attack as a leading cause of death
Description
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
Title
Awareness of heart attack risk factors
Description
The proportion of adult members of the community who identify cardiovascular risk factors
Time Frame
0-2 months and 6-8 months
Title
Number of correctly named heart attack risk factors
Description
The number of correctly named cardiovascular risk factors by adult members of the community
Time Frame
0-2 months and 6-8 months
Title
Awareness of heart attack signs and symptoms
Description
The proportion of adult members of the community aware of heart attack symptoms
Time Frame
0-2 months and 6-8 months
Title
Number of correctly named heart attack signs and symptoms
Description
The number of correctly named ACS symptoms by adult members of the community
Time Frame
0-2 months and 6-8 months
Title
Confidence in knowing how to act
Description
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
Title
Ambulance use in scenarios
Description
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
Title
Rates of Heart Health Checks
Description
Rates of Medicare claims for General Practitioner (GP) Heart Health Checks
Time Frame
16 months
Title
Rates of ACS ED presentations
Description
The rates of ED presentations that are ACS
Time Frame
16 months
Title
Rates of unspecified chest pain ED presentations
Description
Rates of ED presentations that are unspecified chest pain
Time Frame
16 months
Title
ACS ED presentations via GPs
Description
Proportion of ACS ED presentations via General Practitioners
Time Frame
16 months
Title
Rates of ACS survival
Description
The proportion of ACS patients surviving to hospital discharge
Time Frame
16 months
Title
Incidence of OHCA
Description
incidence of out-of-hospital cardiac arrest
Time Frame
16 months
Title
Rates of OHCA
Description
Rates out-of-hospital cardiac arrest survival
Time Frame
16 months
Title
Calls to ambulance for chest pain
Description
Proportion of chest pain (event type 10) calls to ambulance
Time Frame
16 months
Title
Calls to ambulance for non- chest pain
Description
Proportion of non-chest pain emergency calls to ambulance
Time Frame
16 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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.
-
Facility Information:
Facility Name
Victorian LGAs
City
Melbourne
State/Province
Please Select
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Access to data is restricted and is not available for sharing at the individual patient level.
Learn more about this trial
Heart Matters: The Effectiveness of Heart Health Education in Regions at Highest-risk.
We'll reach out to this number within 24 hrs