Heart Matters: A Stepped-wedge Cluster Randomized Controlled Trial of Heart Health Education Targeting Communities at High Risk of Acute Coronary Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,240
- 试验地点
- 2
- 主要终点
- Ambulance use for ACS
研究概览
简要总结
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.
详细描述
Primary objectives:
To determine if targeted heart health education will:
- Increase ambulance use in ACS patients (main primary outcome);
- Decrease patient and prehospital delay times in ACS patients;
- Increase awareness of personal cardiovascular risk and associated factors in adult community members; and
- Increase cardiovascular knowledge and confidence to act to heart attack warning signs in adult community members.
Secondary objectives
- To determine if targeted heart health education:
- Reduces the incidence of out-of-hospital cardiac arrest;
- Improves survival in OHCA patients;
- Improves survival in ACS patients;
- Improves survival and ACS patients;
- Increases presentations to ED for ACS and unspecified chest pain; and
- Increases the rates of calls to ambulance for chest pain and non-chest pain.
- Increases the rate of Heart Health Checks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes are collected blinded to the study allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult residents of the eight local government areas -
排除标准
- •Adults not residing in the eight local government areas.
结局指标
主要结局
Ambulance use for ACS
时间窗: 16 months
The proportion of ACS patients that present to ED by ambulance.
次要结局
- ACS patients prehospital delay times <120 minutes(16 months)
- Median ACS patient delay time(16 months)
- ACS patient delay time <60 minutes(16 months)
- Number of correctly named heart attack risk factors(0-2 months and 6-8 months)
- Awareness of heart attack signs and symptoms(0-2 months and 6-8 months)
- Rates of Heart Health Checks(16 months)
- ACS ED presentations via GPs(16 months)
- Rates of ACS survival(16 months)
- Median ACS patient prehospital delay time(16 months)
- Awareness of own risk of heart attack(0-2 months and 6-8 months)
- Awareness of heart attack risk factors(0-2 months and 6-8 months)
- Confidence in knowing how to act(0-2 months and 6-8 months)
- Ambulance use in scenarios(0-2 months and 6-8 months)
- Rates of unspecified chest pain ED presentations(16 months)
- Rates of OHCA(16 months)
- Calls to ambulance for chest pain(16 months)
- Awareness of heart attack as a leading cause of death(0-2 months and 6-8 months)
- Number of correctly named heart attack signs and symptoms(0-2 months and 6-8 months)
- Rates of ACS ED presentations(16 months)
- Calls to ambulance for non- chest pain(16 months)
- Incidence of OHCA(16 months)
研究者
Janet
Associate Professor
Monash University