Use of MonitorMe in COPD

NCT04108143 | Completed

• 1 other identifier: 181003
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Telehealth; Telemonitoring; COPD

Outcome Measures

Primary Outcomes (1)

• Oxygen Saturation

  Agreement between measurements made by MonitorMe and healthcare professionals

  Day 0 to 28

Secondary Outcomes (11)

• Temperature

  Day 0 to 28

• Heart rate/pulse rate

  Day 0 to 28

• Adverse event rate

  Day 0 to 28

• Patient compliance

  Day 0 to 28

• Usability

  Day 0 to 28

Study Arms (1)

Intervention

EXPERIMENTAL

MonitorMe device

Device: MonitorMe

Interventions

MonitorMe DEVICE

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.

Intervention

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lincoln: lead
• Sanandco Ltd: collaborator
• National Health Service, United Kingdom: collaborator

Study Sites (2)

University of Lincoln

Lincoln, LN6 7TS, United Kingdom

Location

Lincolnshire Community Health Services NHS Trust

Lincoln, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aloysius N Siriwardena, MBBS, PhD

  University of Lincoln

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 27, 2019
• Study Start: February 11, 2020
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 11, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)