An interventional study of MonitorMe in Chronic Obstructive Pulmonary Disease, sponsored by University of Lincoln. Completed at 2 sites in United Kingdom. Open to participants aged 40 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by University of Lincoln · Not applicable, Interventional, and Other
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.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 13 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →University of Lincoln is the lead sponsor of 24 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients
Health care professionals
Exclusion Criteria:
Patients
Health care professionals
MonitorMe device
Device: MonitorMe
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.
Oxygen Saturation
Agreement between measurements made by MonitorMe and healthcare professionals
Time frame: Day 0 to 28
Temperature
Agreement between measurements made by MonitorMe and healthcare professionals
Time frame: Day 0 to 28
Heart rate/pulse rate
Agreement between measurements made by MonitorMe and healthcare professionals
Time frame: Day 0 to 28
Adverse event rate
Number of reported adverse events during study period
Time frame: Day 0 to 28
Patient compliance
Number of MonitorMe automated calls completed during observation period
Time frame: Day 0 to 28
Usability
Number of unsuccessful data transmissions or missing data (confidence values of MonitorMe)
Time frame: Day 0 to 28
Acceptance/experience of MonitorMe for patients
Semi-structured interviews
Time frame: Day 28 to 84
Acceptance/experience of MonitorMe for health care professionals
Semi-structured interviews
Time frame: Day 28 to 84
Self-reported disease specific assessment of quality of life
Chronic Respiratory Questionnaire
Time frame: Day 0 and Day 28
Recruitment rates
Time taken to achieve planned sample size
Time frame: 1 year
Consent rate
Number of eligible patients willing to consent to take part in the study
Time frame: 1 year
Retention rate
Number of patients who complete the study
Time frame: Day 0 to 28
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of Lincoln