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

Acute Coronary Syndrome Clinical Trial

Official title:

Heart Matters: A Stepped-wedge Cluster Randomized Controlled Trial of Heart Health Education Targeting Communities at High Risk of Acute Coronary Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04995900
• Other study ID #: 291276657
• Secondary ID: 1180282
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: June 2023
• Source: Monash University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2240
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

-

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Myocardial Infarction
• Myocardial Infarction, Acute
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Australia	Victorian LGAs	Melbourne	Please Select

Sponsors (4)

Lead Sponsor	Collaborator
Monash University	Ambulance Victoria, Department of Health, Victorian Government, National Heart Foundation, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulance use for ACS	The proportion of ACS patients that present to ED by ambulance.	16 months
Secondary	Median ACS patient delay time	The median ACS patients delay time (time from symptom onset to decision to seek medical attention).	16 months
Secondary	ACS patient delay time <60 minutes	The proportion of ACS patients with patient delay times <60 minutes	16 months
Secondary	Median ACS patient prehospital delay time	The median ACS patient prehospital delay time (time from symptom onset to arrival at hospital).	16 months
Secondary	ACS patients prehospital delay times <120 minutes	The proportion of ACS patients with prehospital delay times <120 minutes	16 months
Secondary	Awareness of own risk of heart attack	The proportion of adult members of the community who are aware of their own risk of heart attack.	0-2 months and 6-8 months
Secondary	Awareness of heart attack as a leading cause of death	The proportion of adult members of the community who identify heart disease a leading cause of death	0-2 months and 6-8 months
Secondary	Awareness of heart attack risk factors	The proportion of adult members of the community who identify cardiovascular risk factors	0-2 months and 6-8 months
Secondary	Number of correctly named heart attack risk factors	The number of correctly named cardiovascular risk factors by adult members of the community	0-2 months and 6-8 months
Secondary	Awareness of heart attack signs and symptoms	The proportion of adult members of the community aware of heart attack symptoms	0-2 months and 6-8 months
Secondary	Number of correctly named heart attack signs and symptoms	The number of correctly named ACS symptoms by adult members of the community	0-2 months and 6-8 months
Secondary	Confidence in knowing how to act	The proportion adult members of the community who are confident about what they would do if experiencing a heart attack	0-2 months and 6-8 months
Secondary	Ambulance use in scenarios	The proportion adult members of the community who correctly state they would call an ambulance for two heart attack scenarios.	0-2 months and 6-8 months
Secondary	Rates of Heart Health Checks	Rates of Medicare claims for General Practitioner (GP) Heart Health Checks	16 months
Secondary	Rates of ACS ED presentations	The rates of ED presentations that are ACS	16 months
Secondary	Rates of unspecified chest pain ED presentations	Rates of ED presentations that are unspecified chest pain	16 months
Secondary	ACS ED presentations via GPs	Proportion of ACS ED presentations via General Practitioners	16 months
Secondary	Rates of ACS survival	The proportion of ACS patients surviving to hospital discharge	16 months
Secondary	Incidence of OHCA	incidence of out-of-hospital cardiac arrest	16 months
Secondary	Rates of OHCA	Rates out-of-hospital cardiac arrest survival	16 months
Secondary	Calls to ambulance for chest pain	Proportion of chest pain (event type 10) calls to ambulance	16 months
Secondary	Calls to ambulance for non- chest pain	Proportion of non-chest pain emergency calls to ambulance	16 months