Use of MonitorMe in COPD
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|ClinicalTrials.gov Identifier: NCT04108143|
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : April 27, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Device: MonitorMe||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of MonitorMe in COPD: a Mixed-methods Feasibility Study|
|Actual Study Start Date :||February 11, 2020|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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 [ Time Frame: Day 0 to 28 ]Agreement between measurements made by MonitorMe and healthcare professionals
- Temperature [ Time Frame: Day 0 to 28 ]Agreement between measurements made by MonitorMe and healthcare professionals
- Heart rate/pulse rate [ Time Frame: Day 0 to 28 ]Agreement between measurements made by MonitorMe and healthcare professionals
- Adverse event rate [ Time Frame: Day 0 to 28 ]Number of reported adverse events during study period
- Patient compliance [ Time Frame: Day 0 to 28 ]Number of MonitorMe automated calls completed during observation period
- Usability [ Time Frame: Day 0 to 28 ]Number of unsuccessful data transmissions or missing data (confidence values of MonitorMe)
- Acceptance/experience of MonitorMe for patients [ Time Frame: Day 28 to 84 ]Semi-structured interviews
- Acceptance/experience of MonitorMe for health care professionals [ Time Frame: Day 28 to 84 ]Semi-structured interviews
- Self-reported disease specific assessment of quality of life [ Time Frame: Day 0 and Day 28 ]Chronic Respiratory Questionnaire
- Recruitment rates [ Time Frame: 1 year ]Time taken to achieve planned sample size
- Consent rate [ Time Frame: 1 year ]Number of eligible patients willing to consent to take part in the study
- Retention rate [ Time Frame: Day 0 to 28 ]Number of patients who complete the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04108143
|Contact: Aloysius N Siriwardena, MBBS, PhD||+44 (0)1522 email@example.com|
|Contact: Arwel W Jones, PhD||+44 (0)1522 firstname.lastname@example.org|
|University of Lincoln||Recruiting|
|Lincoln, United Kingdom, LN6 7TS|
|Contact: Arwel W Jones, PhD email@example.com|
|Lincolnshire Community Health Services NHS Trust||Recruiting|
|Lincoln, United Kingdom|
|Contact: Debbie Jeffrey firstname.lastname@example.org|
|Principal Investigator:||Aloysius N Siriwardena, MBBS, PhD||University of Lincoln|