A Randomized Study of the Effectiveness of an Integrated Tele-monitoring and Patient-centric Health Coaching Strategy (Tele-HC) in Adult Patients Recently Hospitalized With Acute Decompensated Heart Failure (ADHF) Compared to Standard Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 112
- 试验地点
- 10
- 主要终点
- Hospital Readmission
研究概览
简要总结
This study evaluates the effectiveness of remote tele-monitoring and health coaching in helping to reduce hospitalizations in heart failure patients. Half of participants will receive tele-monitoring and health coaching, while the other half will receive standard health care provided by their chosen provider.
详细描述
Tele-monitoring involves a personal monitoring system used to analyze data to provide relevant health information back to the treating clinician and the user. The monitoring system remotely monitors electrocardiographic (ECG) signals, heart rate, breathing rate, and activity levels. Additional devices will be integrated with the monitoring device to assess blood pressure and weight.
Health Coaching involves a team of health care professionals including a registered nurse (RN). The health care team creates a plan specific to the patient and provides guidance on nutrition' medications, and exercise. The data collected by the remote monitoring device will assist the care team in patient management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Hospitalized with primary or secondary diagnosis of Acute Decompensated Heart Failure (one or more of these symptoms: shortness of breath, orthopnea or edema AND one or more of these signs: rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography)
- •Adult patients >18 years old
排除标准
- •Overall life expectancy < 1 year
- •Known skin allergy to adhesives (hydrocolloid, silicone, acrylic)
- •Active systemic infection
- •Pregnant or lactating
- •End stage renal disease on dialysis
- •Subject or caregiver is not visually and tactile capable of smartphone and home device usage
- •Inadequate cell phone coverage (including international patients or international travel during study period)
- •Subject or legal guardian is not willing and able to provide appropriate informed consent
结局指标
主要结局
Hospital Readmission
时间窗: 60 days
Occurrence of all-cause hospital readmissions or death within 60 days
次要结局
- Number of Readmissions or Visits(60 days)
- Mortality(60 days)
研究者
Charles J. Bruce
Professor of Medicine, College of Medicine
Mayo Clinic