Clinical trial NCT04995900: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Myocardial Infarction, Acute
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: National Heart Foundation, Australia
name: Department of Health, Victorian Government
name: Ambulance Victoria
First posted: 2021-08-09
Enrollment: 2240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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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Primary outcomes:
measure: Ambulance use for ACS
timeFrame: 16 months
Secondary outcomes:
measure: Median ACS patient delay time
timeFrame: 16 months
measure: ACS patient delay time <60 minutes
timeFrame: 16 months
measure: Median ACS patient prehospital delay time
timeFrame: 16 months
measure: ACS patients prehospital delay times <120 minutes
timeFrame: 16 months
measure: Awareness of own risk of heart attack
timeFrame: 0-2 months and 6-8 months
measure: Awareness of heart attack as a leading cause of death
timeFrame: 0-2 months and 6-8 months
measure: Awareness of heart attack risk factors
timeFrame: 0-2 months and 6-8 months
measure: Number of correctly named heart attack risk factors
timeFrame: 0-2 months and 6-8 months
measure: Awareness of heart attack signs and symptoms
timeFrame: 0-2 months and 6-8 months
measure: Number of correctly named heart attack signs and symptoms
timeFrame: 0-2 months and 6-8 months
measure: Confidence in knowing how to act
timeFrame: 0-2 months and 6-8 months
measure: Ambulance use in scenarios
timeFrame: 0-2 months and 6-8 months
measure: Rates of Heart Health Checks
timeFrame: 16 months
measure: Rates of ACS ED presentations
timeFrame: 16 months
measure: Rates of unspecified chest pain ED presentations
timeFrame: 16 months
measure: ACS ED presentations via GPs
timeFrame: 16 months
measure: Rates of ACS survival
timeFrame: 16 months
measure: Incidence of OHCA
timeFrame: 16 months
measure: Rates of OHCA
timeFrame: 16 months
measure: Calls to ambulance for chest pain
timeFrame: 16 months
measure: Calls to ambulance for non- chest pain
timeFrame: 16 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Victorian LGAs
state: Please Select
Study officials:
References: