Use of MonitorMe in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04108143
• Other study ID #: 181003
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 11, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: University of Lincoln
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Lincolnshire Community Health Services NHS Trust	Lincoln
United Kingdom	University of Lincoln	Lincoln

Sponsors (3)

Lead Sponsor	Collaborator
University of Lincoln	National Health Service, United Kingdom, Sanandco Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

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