Ignite Creation Date:
2024-05-06 @ 4:28 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04995900
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2021-07-30
Brief Title:
Heart Matters The Effectiveness of Heart Health Education in Regions at Highest-risk
Sponsor:
Monash University
Organization:
Monash University
Study Overview
Official Title:
Heart Matters A Stepped-wedge Cluster Randomized Controlled Trial of Heart Health Education Targeting Communities at High Risk of Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1180282 | OTHER_GRANT | National Health and Medical Research Council NHMRC | None |