Use of MonitorMe in COPD
Use of MonitorMe in COPD: a Mixed-methods Feasibility Study
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Lincoln、英国、LN6 7TS
- University of Lincoln
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Lincoln、英国
- Lincolnshire Community Health Services NHS Trust
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Patients
- 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
Exclusion Criteria:
Patients
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Intervention
MonitorMe device
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MonitorMe replaces the users existing telephone and for the majority of time is used as their ordinary telephone.
At a known and set time of day for 4 weeks, participants will receive an automated MonitorMe telephone call.
The participant answers a health and well-being automated script by pressing key pad numbers.
At the same time vital signs data are collected.
The responses and vital signs data, together with confidence values are then transmitted via telephone lines to an electronic patient record.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Oxygen Saturation
大体时间:Day 0 to 28
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Agreement between measurements made by MonitorMe and healthcare professionals
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Day 0 to 28
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Temperature
大体时间:Day 0 to 28
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Agreement between measurements made by MonitorMe and healthcare professionals
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Day 0 to 28
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Heart rate/pulse rate
大体时间:Day 0 to 28
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Agreement between measurements made by MonitorMe and healthcare professionals
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Day 0 to 28
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Adverse event rate
大体时间:Day 0 to 28
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Number of reported adverse events during study period
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Day 0 to 28
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Patient compliance
大体时间:Day 0 to 28
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Number of MonitorMe automated calls completed during observation period
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Day 0 to 28
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Usability
大体时间:Day 0 to 28
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Number of unsuccessful data transmissions or missing data (confidence values of MonitorMe)
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Day 0 to 28
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Acceptance/experience of MonitorMe for patients
大体时间:Day 28 to 84
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Semi-structured interviews
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Day 28 to 84
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Acceptance/experience of MonitorMe for health care professionals
大体时间:Day 28 to 84
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Semi-structured interviews
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Day 28 to 84
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Self-reported disease specific assessment of quality of life
大体时间:Day 0 and Day 28
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Chronic Respiratory Questionnaire
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Day 0 and Day 28
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Recruitment rates
大体时间:1 year
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Time taken to achieve planned sample size
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1 year
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Consent rate
大体时间:1 year
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Number of eligible patients willing to consent to take part in the study
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1 year
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Retention rate
大体时间:Day 0 to 28
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Number of patients who complete the study
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Day 0 to 28
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合作者和调查者
调查人员
- 首席研究员:Aloysius N Siriwardena, MBBS, PhD、University of Lincoln
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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