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临床试验/NCT04108143
NCT04108143
已完成
不适用

Use of MonitorMe in COPD: a Mixed-methods Feasibility Study

University of Lincoln2 个研究点 分布在 1 个国家目标入组 13 人2020年2月11日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Chronic Obstructive Pulmonary Disease
发起方
University of Lincoln
入组人数
13
试验地点
2
主要终点
Oxygen Saturation
状态
已完成
最后更新
去年

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.

注册库
clinicaltrials.gov
开始日期
2020年2月11日
结束日期
2022年12月31日
最后更新
去年
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Sponsor

入排标准

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

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)

研究点 (2)

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