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

Monash University

Status: Completed

Conditions: Acute Coronary Syndrome; Myocardial Infarction, Acute

Treatments: Other: Community education

Study type: Interventional

Funder types: Other

Identifiers

NCT04995900

1180282 (Other Grant/Funding Number)

291276657

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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2,240 participants in 2 patient groups

Intervention

Experimental group

Description:

Intervention period with active Heart Matters education delivered

Treatment:

Other: Community education

Control

No Intervention group

Description:

Control period with no Heart Matters education delivered.