- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04995900
Heart Matters: The Effectiveness of Heart Health Education in Regions at Highest-risk.
Heart Matters: A Stepped-wedge Cluster Randomized Controlled Trial of Heart Health Education Targeting Communities at High Risk of Acute Coronary Syndrome.
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Please Select
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Melbourne, Please Select, Australia, 3004
- Victorian LGAs
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria: Adult residents of the eight local government areas -
Exclusion Criteria: Adults not residing in the eight local government areas.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Intervention period with active Heart Matters education delivered
|
Heart Matters coordinators will deliver heart health education to the community using HM materials and Partner resources.
Other Names:
|
No Intervention: Control
Control period with no Heart Matters education delivered.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ambulance use for ACS
Time Frame: 16 months
|
The proportion of ACS patients that present to ED by ambulance.
|
16 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
16 months
|
ACS patient delay time <60 minutes
Time Frame: 16 months
|
The proportion of ACS patients with patient delay times <60 minutes
|
16 months
|
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).
|
16 months
|
ACS patients prehospital delay times <120 minutes
Time Frame: 16 months
|
The proportion of ACS patients with prehospital delay times <120 minutes
|
16 months
|
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.
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0-2 months and 6-8 months
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Awareness of heart attack as a leading cause of death
Time Frame: 0-2 months and 6-8 months
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The proportion of adult members of the community who identify heart disease a leading cause of death
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0-2 months and 6-8 months
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Awareness of heart attack risk factors
Time Frame: 0-2 months and 6-8 months
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The proportion of adult members of the community who identify cardiovascular risk factors
|
0-2 months and 6-8 months
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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
|
0-2 months and 6-8 months
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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
|
0-2 months and 6-8 months
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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
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0-2 months and 6-8 months
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Confidence in knowing how to act
Time Frame: 0-2 months and 6-8 months
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The proportion adult members of the community who are confident about what they would do if experiencing a heart attack
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0-2 months and 6-8 months
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Ambulance use in scenarios
Time Frame: 0-2 months and 6-8 months
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The proportion adult members of the community who correctly state they would call an ambulance for two heart attack scenarios.
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0-2 months and 6-8 months
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Rates of Heart Health Checks
Time Frame: 16 months
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Rates of Medicare claims for General Practitioner (GP) Heart Health Checks
|
16 months
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Rates of ACS ED presentations
Time Frame: 16 months
|
The rates of ED presentations that are ACS
|
16 months
|
Rates of unspecified chest pain ED presentations
Time Frame: 16 months
|
Rates of ED presentations that are unspecified chest pain
|
16 months
|
ACS ED presentations via GPs
Time Frame: 16 months
|
Proportion of ACS ED presentations via General Practitioners
|
16 months
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Rates of ACS survival
Time Frame: 16 months
|
The proportion of ACS patients surviving to hospital discharge
|
16 months
|
Incidence of OHCA
Time Frame: 16 months
|
incidence of out-of-hospital cardiac arrest
|
16 months
|
Rates of OHCA
Time Frame: 16 months
|
Rates out-of-hospital cardiac arrest survival
|
16 months
|
Calls to ambulance for chest pain
Time Frame: 16 months
|
Proportion of chest pain (event type 10) calls to ambulance
|
16 months
|
Calls to ambulance for non- chest pain
Time Frame: 16 months
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Proportion of non-chest pain emergency calls to ambulance
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16 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 291276657
- 1180282 (Other Grant/Funding Number: National Health and Medical Research Council (NHMRC))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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