Use of MonitorMe in COPD: a Mixed-methods Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 3
- 主要终点
- Oxygen Saturation
研究概览
简要总结
MonitorMe is a telephone device intended for the non-critical monitoring of vital signs in a domestic environment with the ability to automatically transmit data to a remote location via basic telephone connectivity.
MonitorMe's low-cost, call automation and simple to use technology (i.e. based on the principles of an ordinary plug-in telephone) make it appropriate for a wide number of care pathways. It eliminates the need for a modem or broadband and avoids the challenges of less reliable smart phone technology. Typical use scenarios include remote monitoring of individual or multiple chronic disease states such as COPD to improve patient outcomes including prevention of emergency admissions.
There is growing interest in the use of home telemonitoring in COPD in order to facilitate the management of the increasing numbers of patients and pressures on the NHS. Despite the positive effects of telemonitoring in conditions such as heart failure, benefits remain unproven in COPD and further work is required before wide-scale use.
Furthermore, until now the evaluation of telecare and telehealth developments has focused mainly on effectiveness and efficiency, whereas their social, and ethical implications in particular, have not been explored in depth. We will also explore ethical issues related to the use of telehealth systems, from both the patients' and the healthcare professionals' perspective.
The current feasibility study is designed to assess the acceptability, usability and validity of MonitorMe within one of its intended purposes i.e. remote monitoring of individual or multiple chronic disease states such as COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults diagnosed with any severity of COPD (according to British Thoracic Society criteria, i.e. >10 pack year smoking history and post bronchodilator spirometry FEV1/FVC ratio <0.70 and FEV<80%)
- •Listed on referral lists or COPD registers within Lincolnshire Community Health Services NHS Trust or NHS South West Lincolnshire CCG
- •Health care professionals
- •Involved in implementing the device within Lincolnshire Community Health Services NHS Trust or NHS South West Lincolnshire CCG
- •Provide informed consent to participate in an interview
排除标准
- •Inability or unwillingness to sign informed consent
- •No active telephone line in home
- •COPD exacerbation within the previous 6 weeks.
- •Mental health, cognitive or neurological conditions that would make study participation inappropriate
- •Life expectancy < 6 months
- •Implanted pacemaker
- •Hearing or visual ailments that would preclude the use of the MonitorMe device
- •Inability to use both hands (i.e. hold handset in one hand and use keypad with the other at same time)
- •Inability to understand verbal English
- •Health care professionals
- •Not involved in implementing the device within Lincolnshire Community Health Services NHS Trust or NHS South West Lincolnshire CCG
- •Unable/unwilling informed consent to participate in an interview
结局指标
主要结局
Oxygen Saturation
时间窗: Day 0 to 28
Agreement between measurements made by MonitorMe and healthcare professionals
次要结局
- Temperature(Day 0 to 28)
- Patient compliance(Day 0 to 28)
- Acceptance/experience of MonitorMe for health care professionals(Day 28 to 84)
- Adverse event rate(Day 0 to 28)
- Heart rate/pulse rate(Day 0 to 28)
- Usability(Day 0 to 28)
- Acceptance/experience of MonitorMe for patients(Day 28 to 84)
- Self-reported disease specific assessment of quality of life(Day 0 and Day 28)
- Consent rate(1 year)
- Recruitment rates(1 year)
- Retention rate(Day 0 to 28)