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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,240 (actual)
• Sponsor: Monash University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Coronary Syndrome
• Myocardial Infarction, Acute

Interventions

Type	Name	Description
OTHER	Community education	Heart Matters coordinators will deliver heart health education to the community using HM materials and Partner resources.

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2021-08-09
• Last updated: 2023-06-15

Locations

1 site across 1 country: Australia