Remote Monitoring of Heart Failure Patients (REMOTE-HF-1) Study - to Assess Utility of a Mobile Device for Improved Management of At-risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 5
- 主要终点
- Measuring resiliency and reliability of mobile technology for transmitting and retrieval of daily patient vital signs and symptoms as per discharge guideline
研究概览
简要总结
This is planned as a feasibility study. The objective is to evaluate a specially designed patient adherence and monitoring software on standard mobile devices in remote monitoring of heart failure patients.
详细描述
Heart failure is a common cardiovascular problem which is increasing in both prevalence and incidence and associated with substantial morbidity and mortality. The management of heart failure patients is complex and has become a priority world over. Effective methods to keep heart failure patients out of the hospital are essential, both in the interests of the patient's health, as well as to reduce the burden on the health care system.
Heart failure patients should be in a position to provide readings of their weight, blood pressure, fluid intake, medications and other important parameters and communicate this data to care providers using wireless technology. This data should be made available to medical personnel regularly and on a periodic basis. In this manner the health care providers can detect and respond to warning signs or alerts before the patient's condition worsens to warrant a visit to the doctor or a hospital admission with features of heart failure decompensation.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •Subjects of either gender above the age of 18 years
- •The subject is able and willing to provide written informed consent prior to enrollment in the study
- •New York Heart Association (NYHA) classification class of II-IV
- •Left ventricular ejection fraction (LVEF) less than 40%
- •One or more prior hospitalization within the last six months for symptoms, management of heart failure.
排除标准
- •Disability of fingers or upper limbs (unable to use devices)
- •Visually impaired
- •Those unable to read and write
- •Hearing dysfunction
- •Significant cognitive disabilities, mental illness
- •Those who are unable to handle electronic devices
- •Those residing in places outside the local mobile phone coverage
- •Chronic renal failure on renal replacement therapy
- •Patients who may not come for follow up or likely to drop out of the study
- •Those awaiting cardiac transplantation
- •Any illness which may preclude regular follow up
结局指标
主要结局
Measuring resiliency and reliability of mobile technology for transmitting and retrieval of daily patient vital signs and symptoms as per discharge guideline
时间窗: 3 months
Investigators instruct patients to send the clinical data (all measured parameters plus symptoms experienced over the previous 24 hours) via the mobile device every day to the local investigator. The monitoring site maintains a log of all data transmitted and received from the patient and to the patient and, any device malfunction/technical problems, unscheduled SMS/Text messages from patient and to the patient is also to be documented in the case report form for the entire duration of study.
次要结局
- Measuring quality of life score of heart failure patients on a qualitative scale(3 Months)