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

NCT ID: NCT04995900

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-03-31

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.

Conditions

Acute Coronary Syndrome; Myocardial Infarction, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

Intervention period with active Heart Matters education delivered

Group Type: EXPERIMENTAL

Community education

Intervention Type: OTHER

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

Control

Control period with no Heart Matters education delivered.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Community education

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

Intervention Type: OTHER

Other Intervention Names

Local campaign

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart Foundation, Australia

OTHER

Sponsor Role: collaborator

Department of Health, Victorian Government

UNKNOWN

Sponsor Role: collaborator

Ambulance Victoria

OTHER_GOV

Sponsor Role: collaborator

Monash University

OTHER

Sponsor Role: lead

Responsible Party

Janet

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Victorian LGAs

Melbourne, Please Select, Australia

Countries

Australia

References

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.

Reference Type: DERIVED

PMID: 37555197 (View on PubMed)

Other Identifiers

1180282

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

291276657

Identifier Type: -

Identifier Source: org_study_id