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Use of MonitorMe in COPD

2022年8月10日 更新者:University of Lincoln

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

地位

主动,不招人

干预/治疗

研究类型

介入性

注册 (实际的)

13

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Lincoln、英国、LN6 7TS
        • University of Lincoln
      • Lincoln、英国
        • Lincolnshire Community Health Services NHS Trust

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 100年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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.

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
Agreement between measurements made by MonitorMe and healthcare professionals
Day 0 to 28

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
Agreement between measurements made by MonitorMe and healthcare professionals
Day 0 to 28
Heart rate/pulse rate
大体时间:Day 0 to 28
Agreement between measurements made by MonitorMe and healthcare professionals
Day 0 to 28
Adverse event rate
大体时间:Day 0 to 28
Number of reported adverse events during study period
Day 0 to 28
Patient compliance
大体时间:Day 0 to 28
Number of MonitorMe automated calls completed during observation period
Day 0 to 28
Usability
大体时间:Day 0 to 28
Number of unsuccessful data transmissions or missing data (confidence values of MonitorMe)
Day 0 to 28
Acceptance/experience of MonitorMe for patients
大体时间:Day 28 to 84
Semi-structured interviews
Day 28 to 84
Acceptance/experience of MonitorMe for health care professionals
大体时间:Day 28 to 84
Semi-structured interviews
Day 28 to 84
Self-reported disease specific assessment of quality of life
大体时间:Day 0 and Day 28
Chronic Respiratory Questionnaire
Day 0 and Day 28
Recruitment rates
大体时间:1 year
Time taken to achieve planned sample size
1 year
Consent rate
大体时间:1 year
Number of eligible patients willing to consent to take part in the study
1 year
Retention rate
大体时间:Day 0 to 28
Number of patients who complete the study
Day 0 to 28

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Aloysius N Siriwardena, MBBS, PhD、University of Lincoln

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年2月11日

初级完成 (预期的)

2022年10月31日

研究完成 (预期的)

2022年12月31日

研究注册日期

首次提交

2019年9月3日

首先提交符合 QC 标准的

2019年9月26日

首次发布 (实际的)

2019年9月27日

研究记录更新

最后更新发布 (实际的)

2022年8月11日

上次提交的符合 QC 标准的更新

2022年8月10日

最后验证

2022年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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