Effects of Remote Patient Monitoring on Heart Failure Management: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Brain Natriuretic Peptide values
研究概览
简要总结
The purpose of this randomized controlled trial is to determine the effects of a user-centric remote patient monitoring system on heart failure management. Patients attending a Heart Failure Clinic will monitor their weight, blood pressure, ECG, and symptoms at home. The hypothesis is that the remote monitoring system will improve heart failure outcomes through increased self-care and improved clinical management.
详细描述
Poor management of heart failure (HF) has added to the high costs and negative health outcomes from this chronic illness, including frequent hospitalization. HF patients require close monitoring to detect worsening health and to optimize their treatment. However, many patients visit their HF clinicians only once every few months, and perform minimal or no self-monitoring.
Remote patient monitoring is a potential tool to help clinicians and the patients better manage HF. A remote patient monitoring system (home monitoring of vital signs and symptoms) that has been developed with extensive clinician and patient input and testing, will be studied to determine its effects on HF management. Half of one hundred patients from the University Health Network Heart Failure Clinic will be randomly placed into the remote monitoring (RM) group and the other half will be in the control group. Patients in the RM group will monitor their weight, blood pressure, ECG, and symptoms at home for 6 months. This information will be automatically sent from the medical devices wirelessly through Bluetooth to a mobile phone, which will send the information to the data servers. Both clinicians and patients will have access to the data. Patients will get automated reminder telephone calls if they do not take the number of measurements prescribed by their doctors.
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
- •Clinical diagnosis of Heart Failure (NYHA Class II-IV)
- •Out-patients attending the University Health Network Heart Failure Clinic
- •English-speaking and able to read English
- •18 years old or over
排除标准
- •Awaiting heart transplantation
- •Not expected to survive over a year (as determined by their cardiologist)
- •Unable to read text on a mobile phone due to vision disability
- •Unable to self-care due to anxiety, depression, or decreased cognitive function
- •Lack of manual dexterity to accurately press buttons on the mobile phone
结局指标
主要结局
Brain Natriuretic Peptide values
时间窗: Baseline, 6 months
Self-care practices measured through Self-Care of Heart Failure Index scores and interviews
时间窗: baseline, 6 months
Health related quality of life measured through the Minnesota Living with Heart Failure Questionnaire scores and interviews
时间窗: baseline, 6 months
次要结局
- Number of hospitalizations and days in hospital(6 months comparison between intervention and control groups)
- Number of Emergency Department visits(6 month comparison between intervention and control groups)
- All cause mortality(6 month comparison between intervention and control groups)
- Number of Heart Failure Clinic visits(6 month comparison between intervention and control groups)
