Use of MonitorMe in COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MonitorMe
Sponsored by
About this trial
This is an interventional other trial for Chronic Obstructive Pulmonary Disease focused on measuring Telehealth, Telemonitoring, COPD
Eligibility Criteria
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
Sites / Locations
- University of Lincoln
- Lincolnshire Community Health Services NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
MonitorMe device
Outcomes
Primary Outcome Measures
Oxygen Saturation
Agreement between measurements made by MonitorMe and healthcare professionals
Secondary Outcome Measures
Temperature
Agreement between measurements made by MonitorMe and healthcare professionals
Heart rate/pulse rate
Agreement between measurements made by MonitorMe and healthcare professionals
Adverse event rate
Number of reported adverse events during study period
Patient compliance
Number of MonitorMe automated calls completed during observation period
Usability
Number of unsuccessful data transmissions or missing data (confidence values of MonitorMe)
Acceptance/experience of MonitorMe for patients
Semi-structured interviews
Acceptance/experience of MonitorMe for health care professionals
Semi-structured interviews
Self-reported disease specific assessment of quality of life
Chronic Respiratory Questionnaire
Recruitment rates
Time taken to achieve planned sample size
Consent rate
Number of eligible patients willing to consent to take part in the study
Retention rate
Number of patients who complete the study
Full Information
NCT ID
NCT04108143
First Posted
September 3, 2019
Last Updated
August 10, 2022
Sponsor
University of Lincoln
Collaborators
Sanandco Ltd, National Health Service, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT04108143
Brief Title
Use of MonitorMe in COPD
Official Title
Use of MonitorMe in COPD: a Mixed-methods Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Lincoln
Collaborators
Sanandco Ltd, National Health Service, United Kingdom
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Telehealth, Telemonitoring, COPD
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
MonitorMe device
Intervention Type
Device
Intervention Name(s)
MonitorMe
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oxygen Saturation
Description
Agreement between measurements made by MonitorMe and healthcare professionals
Time Frame
Day 0 to 28
Secondary Outcome Measure Information:
Title
Temperature
Description
Agreement between measurements made by MonitorMe and healthcare professionals
Time Frame
Day 0 to 28
Title
Heart rate/pulse rate
Description
Agreement between measurements made by MonitorMe and healthcare professionals
Time Frame
Day 0 to 28
Title
Adverse event rate
Description
Number of reported adverse events during study period
Time Frame
Day 0 to 28
Title
Patient compliance
Description
Number of MonitorMe automated calls completed during observation period
Time Frame
Day 0 to 28
Title
Usability
Description
Number of unsuccessful data transmissions or missing data (confidence values of MonitorMe)
Time Frame
Day 0 to 28
Title
Acceptance/experience of MonitorMe for patients
Description
Semi-structured interviews
Time Frame
Day 28 to 84
Title
Acceptance/experience of MonitorMe for health care professionals
Description
Semi-structured interviews
Time Frame
Day 28 to 84
Title
Self-reported disease specific assessment of quality of life
Description
Chronic Respiratory Questionnaire
Time Frame
Day 0 and Day 28
Title
Recruitment rates
Description
Time taken to achieve planned sample size
Time Frame
1 year
Title
Consent rate
Description
Number of eligible patients willing to consent to take part in the study
Time Frame
1 year
Title
Retention rate
Description
Number of patients who complete the study
Time Frame
Day 0 to 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aloysius N Siriwardena, MBBS, PhD
Organizational Affiliation
University of Lincoln
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Lincoln
City
Lincoln
ZIP/Postal Code
LN6 7TS
Country
United Kingdom
Facility Name
Lincolnshire Community Health Services NHS Trust
City
Lincoln
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of MonitorMe in COPD
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