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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04995900
Enrollment
2240
Registered
2021-08-09
Start date
2022-02-01
Completion date
2023-03-31
Last updated
2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Myocardial Infarction, Acute

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: 1. Increase ambulance use in ACS patients (main primary outcome); 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.

Interventions

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

Sponsors

National Heart Foundation, Australia
CollaboratorOTHER
Department of Health, Victorian Government
CollaboratorUNKNOWN
Ambulance Victoria
CollaboratorOTHER_GOV
Monash University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcomes are collected blinded to the study allocation.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult residents of the eight local government areas -

Exclusion criteria

Adults not residing in the eight local government areas. \-

Design outcomes

Primary

MeasureTime frameDescription
Ambulance use for ACS16 monthsThe proportion of ACS patients that present to ED by ambulance.

Secondary

MeasureTime frameDescription
ACS patient delay time <60 minutes16 monthsThe proportion of ACS patients with patient delay times \<60 minutes
Median ACS patient prehospital delay time16 monthsThe median ACS patient prehospital delay time (time from symptom onset to arrival at hospital).
ACS patients prehospital delay times <120 minutes16 monthsThe proportion of ACS patients with prehospital delay times \<120 minutes
Awareness of own risk of heart attack0-2 months and 6-8 monthsThe 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 death0-2 months and 6-8 monthsThe proportion of adult members of the community who identify heart disease a leading cause of death
Awareness of heart attack risk factors0-2 months and 6-8 monthsThe proportion of adult members of the community who identify cardiovascular risk factors
Number of correctly named heart attack risk factors0-2 months and 6-8 monthsThe number of correctly named cardiovascular risk factors by adult members of the community
Awareness of heart attack signs and symptoms0-2 months and 6-8 monthsThe proportion of adult members of the community aware of heart attack symptoms
Number of correctly named heart attack signs and symptoms0-2 months and 6-8 monthsThe number of correctly named ACS symptoms by adult members of the community
Confidence in knowing how to act0-2 months and 6-8 monthsThe proportion adult members of the community who are confident about what they would do if experiencing a heart attack
Median ACS patient delay time16 monthsThe median ACS patients delay time (time from symptom onset to decision to seek medical attention).
Rates of Heart Health Checks16 monthsRates of Medicare claims for General Practitioner (GP) Heart Health Checks
Rates of ACS ED presentations16 monthsThe rates of ED presentations that are ACS
Rates of unspecified chest pain ED presentations16 monthsRates of ED presentations that are unspecified chest pain
ACS ED presentations via GPs16 monthsProportion of ACS ED presentations via General Practitioners
Rates of ACS survival16 monthsThe proportion of ACS patients surviving to hospital discharge
Incidence of OHCA16 monthsincidence of out-of-hospital cardiac arrest
Rates of OHCA16 monthsRates out-of-hospital cardiac arrest survival
Calls to ambulance for chest pain16 monthsProportion of chest pain (event type 10) calls to ambulance
Calls to ambulance for non- chest pain16 monthsProportion of non-chest pain emergency calls to ambulance
Ambulance use in scenarios0-2 months and 6-8 monthsThe proportion adult members of the community who correctly state they would call an ambulance for two heart attack scenarios.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026