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

NCT04995900 | Completed

• 2 other identifiers: 2912766571180282
• Study Type: interventional
• Target: 2,240
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Myocardial Infarction, Acute

Outcome Measures

Primary Outcomes (1)

• Ambulance use for ACS

  The proportion of ACS patients that present to ED by ambulance.

  16 months

Secondary Outcomes (21)

• Median ACS patient delay time

  16 months

• ACS patient delay time <60 minutes

  16 months

• Median ACS patient prehospital delay time

  16 months

• ACS patients prehospital delay times <120 minutes

  16 months

• Awareness of own risk of heart attack

  0-2 months and 6-8 months

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention period with active Heart Matters education delivered

Other: Community education

Control

NO INTERVENTION

Control period with no Heart Matters education delivered.

Interventions

Community education OTHER

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

Also known as: Local campaign

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Monash University: lead
• National Heart Foundation, Australia: collaborator
• Department of Health, Victorian Government: collaborator
• Ambulance Victoria: collaborator

Study Sites (1)

Victorian LGAs

Melbourne, Please Select, 3004, Australia

Location

Related Publications (1)

• Bray JE, Nehme Z, Finn JC, Kasza J, Clark RA, Stub D, Cadilhac DA, Buttery AK, Woods J, Kim J, Smith BJ, Smith K, Cartledge S, Beauchamp A, Dodge N, Walker T, Flemming-Judge E, Chow C, Stewart M, Cox N, van Gaal W, Nadurata V, Cameron P. A protocol for the Heart Matters stepped wedge cluster randomised trial: The effectiveness of heart attack education in regions at highest-risk. Resusc Plus. 2023 Jul 25;15:100431. doi: 10.1016/j.resplu.2023.100431. eCollection 2023 Sep.

  PMID: 37555197 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes are collected blinded to the study allocation.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 9, 2021
• Study Start: February 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)