A Risk-guided Disease Management and Tele-rehabilitation Program to Reduce Re-admissions in Coronary Artery Disease (Risk-Guided CAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Hospitalization or death
研究概览
简要总结
Coronary artery disease (CAD) is the number one killer of Australians with a high risk for a recurrent event(s) and hospital readmission. Many of these readmissions can be prevented with better management to control the problem of CAD. A disease management program, led by nurses who interact with other health professionals/providers, can help with education and counselling, taking medications correctly and making healthy lifestyle changes for higher risk patients. Newer models of disease management programs make use of mobile devices (such as an "app") and telehealth (by phone or video call) to monitor and manage health which could facilitate CAD management. Therefore, the aim of this study is to test this type of disease management program (DMP) compared to standard care for reducing hospital readmissions or death in people with CAD who are at high risk of being readmitted. The Investigators envisage that a novel Risk-Guided DMP will be favorable to patients and associated with high-level participation. The Investigators hypothesize that high-risk patients randomized to Risk-Guided CAD will have reduced hospital readmissions or death compared with those randomized to usual care.
详细描述
The Investigators aim to test a nurse-led, technology-enabled model of health care delivery, called Risk-Guided DMP, to reduce readmissions following CAD, thereby enhancing recovery and survivorship.
The Investigators envisage that a novel Risk-Guided DMP will be favorable to patients and associated with high-level participation. The Investigators hypothesize reduced hospital readmissions or death for high-risk patients randomized to Risk-Guided DMP compared to usual care.
Methods
This proposed study is an effectiveness and feasibility trial of a risk guided DMP to reduce hospital readmissions in CAD patients. The Investigators seek to do this by adopting innovative approaches to:
i) a community-based secondary prevention DMP, ii) supported by a novel m-Health app (SmartCR developed by CardiHab) to address components of a Cardiac Rehabilitation (CR) program, and iii) selection of higher risk patients for appropriate management by validated (PEGASUS-TIMI 54) criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
There are no other parties who will be masked in the clinical trial.
入排标准
- 年龄范围
- 30 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 30 to 74 years; AND
- •Hospitalised with CAD or other eligible cardiac procedure or condition including acute myocardial infarction (STEMI or NSTEMI), unstable angina, coronary artery bypass grafting or percutaneous coronary intervention; AND
- •Defined as higher risk (score >= 5) by PEGASUS-TIMI 54 criteria; AND
- •Eligible for Medicare.
排除标准
- •Inability to provide written informed consent; OR
- •Non-English speaking; OR
- •Inability to attend clinic visits; OR
- •Inability to engage with an app due to low technical literacy or lacking access to a smart phone or wi-fi; OR
- •Hospitalised with a primary diagnosis of heart failure; OR
- •eGFR <30 ml/min/1.73m2 (CKD stage 4 or stage 5); OR
- •Valve disease only; OR
- •Requiring palliative care; OR
- •Concomitant terminal non-cardiac illnesses that could influence 12-month prognosis (e.g. advanced malignancy); OR
- •Participating in another study with a potential but unknown effect on outcome.
结局指标
主要结局
Hospitalization or death
时间窗: 90 days post discharge
Unplanned all-cause hospital readmission or death
次要结局
- Provider adherence to best practice guidelines(12 months post discharge)
- Risk factor control - blood pressure(12 months post discharge)
- Health well-being(12 months post discharge)
- Risk factor control - lipids(12 months post discharge)
- Hospitalization or death(30 days post discharge)