Use of MonitorMe in COPD

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: MonitorMe

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Lincoln, United Kingdom, LN6 7TS
    • University of Lincoln
  • Lincoln, United Kingdom
    • Lincolnshire Community Health Services NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Saturation	Agreement between measurements made by MonitorMe and healthcare professionals	Day 0 to 28

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Lincoln
• Collaborators: National Health Service, United Kingdom; Sanandco Ltd
• Investigators: Principal Investigator: Aloysius N Siriwardena, MBBS, PhD, University of Lincoln

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2020
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: COPD; Telemonitoring; Telehealth
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 181003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No