Use of MonitorMe in COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Device: MonitorMe
- Registration Number
- NCT04108143
- Lead Sponsor
- University of Lincoln
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention MonitorMe MonitorMe device
- Primary Outcome Measures
Name Time Method Oxygen Saturation Day 0 to 28 Agreement between measurements made by MonitorMe and healthcare professionals
- Secondary Outcome Measures
Name Time Method Temperature Day 0 to 28 Agreement between measurements made by MonitorMe and healthcare professionals
Patient compliance Day 0 to 28 Number of MonitorMe automated calls completed during observation period
Acceptance/experience of MonitorMe for health care professionals Day 28 to 84 Semi-structured interviews
Adverse event rate Day 0 to 28 Number of reported adverse events during study period
Heart rate/pulse rate Day 0 to 28 Agreement between measurements made by MonitorMe and healthcare professionals
Usability Day 0 to 28 Number of unsuccessful data transmissions or missing data (confidence values of MonitorMe)
Acceptance/experience of MonitorMe for patients Day 28 to 84 Semi-structured interviews
Self-reported disease specific assessment of quality of life Day 0 and Day 28 Chronic Respiratory Questionnaire
Consent rate 1 year Number of eligible patients willing to consent to take part in the study
Recruitment rates 1 year Time taken to achieve planned sample size
Retention rate Day 0 to 28 Number of patients who complete the study
Trial Locations
- Locations (2)
University of Lincoln
🇬🇧Lincoln, United Kingdom
Lincolnshire Community Health Services NHS Trust
🇬🇧Lincoln, United Kingdom