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OpenTrials
Completed

NCT Number: NCT04108143

Use of MonitorMe in COPD

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.

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Key information

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lincolnshire Community Health Services NHS Trust, Lincoln, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Oxygen Saturation

    Time frame: Day 0 to 28

    Agreement between measurements made by MonitorMe and healthcare professionals

Secondary outcomes

  1. Temperature

    Time frame: Day 0 to 28

    Agreement between measurements made by MonitorMe and healthcare professionals

  2. Heart rate/pulse rate

    Time frame: Day 0 to 28

    Agreement between measurements made by MonitorMe and healthcare professionals

  3. Adverse event rate

    Time frame: Day 0 to 28

    Number of reported adverse events during study period

  4. Patient compliance

    Time frame: Day 0 to 28

    Number of MonitorMe automated calls completed during observation period

  5. Usability

    Time frame: Day 0 to 28

    Number of unsuccessful data transmissions or missing data (confidence values of MonitorMe)

  6. Acceptance/experience of MonitorMe for patients

    Time frame: Day 28 to 84

    Semi-structured interviews

  7. Acceptance/experience of MonitorMe for health care professionals

    Time frame: Day 28 to 84

    Semi-structured interviews

  8. Self-reported disease specific assessment of quality of life

    Time frame: Day 0 and Day 28

    Chronic Respiratory Questionnaire

  9. Recruitment rates

    Time frame: 1 year

    Time taken to achieve planned sample size

  10. Consent rate

    Time frame: 1 year

    Number of eligible patients willing to consent to take part in the study

  11. Retention rate

    Time frame: Day 0 to 28

    Number of patients who complete the study

Sponsors and collaborators

Lead sponsor

University of Lincoln

Other

Collaborators

  • National Health Service, United Kingdom
  • Sanandco Ltd

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 27, 2019
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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