Chronic Obstructive Pulmonary DiseaseNCT04108143
Use of MonitorMe in COPD
A study testing MonitorMe in people with Chronic Obstructive Pulmonary Disease, run by University of Lincoln at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- MonitorMe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 11 Feb 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Lincoln
Lincoln, LN6 7TS
Lincolnshire Community Health Services NHS Trust
Lincoln
About this study
Official title: 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.
Read more
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
- Being tested
- MonitorMe
- Keywords
- Telehealth, Telemonitoring, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonitorMeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | MonitorMe device Receives: Device: MonitorMe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Saturation
Agreement between measurements made by MonitorMe and healthcare professionals
Measured: Day 0 to 28
Secondary outcomes (11)
Temperature
Agreement between measurements made by MonitorMe and healthcare professionals
Measured: Day 0 to 28
Heart rate/pulse rate
Agreement between measurements made by MonitorMe and healthcare professionals
Measured: Day 0 to 28
Adverse event rate
Number of reported adverse events during study period
Measured: Day 0 to 28
Patient compliance
Number of MonitorMe automated calls completed during observation period
Measured: Day 0 to 28
Usability
Number of unsuccessful data transmissions or missing data (confidence values of MonitorMe)
Measured: Day 0 to 28
Acceptance/experience of MonitorMe for patients
Semi-structured interviews
Measured: Day 28 to 84
Acceptance/experience of MonitorMe for health care professionals
Semi-structured interviews
Measured: Day 28 to 84
Self-reported disease specific assessment of quality of life
Chronic Respiratory Questionnaire
Measured: Day 0 and Day 28
Recruitment rates
Time taken to achieve planned sample size
Measured: 1 year
Consent rate
Number of eligible patients willing to consent to take part in the study
Measured: 1 year
Retention rate
Number of patients who complete the study
Measured: Day 0 to 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start11 Feb 2020
- Primary completion31 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- Sanandco Ltd, National Health Service, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Aloysius N Siriwardena, MBBS, PhD, Principal investigator, University of Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108143
- Sponsor's protocol ID
- 181003
- Status last verified
- May 2023
- First submitted
- 3 Sep 2019
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of MonitorMe in COPD: a Mixed-methods Feasibility Study
- ClinicalTrials.gov ID
- NCT04108143
- Acronym / sponsor ID
- 181003
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Telehealth, Telemonitoring, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of LincolnUniversity, hospital or other
- Collaborators
- Sanandco Ltd, National Health Service, United Kingdom
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: MonitorMeMonitorMe device |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MonitorMeMonitorMe 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. | Device | Intervention |
Primary outcome
Oxygen Saturation
Time frame: Day 0 to 28
Agreement between measurements made by MonitorMe and healthcare professionals
11 secondary outcomes
Temperature
Time frame: Day 0 to 28
Heart rate/pulse rate
Time frame: Day 0 to 28
Adverse event rate
Time frame: Day 0 to 28
Patient compliance
Time frame: Day 0 to 28
Usability
Time frame: Day 0 to 28
Acceptance/experience of MonitorMe for patients
Time frame: Day 28 to 84
Acceptance/experience of MonitorMe for health care professionals
Time frame: Day 28 to 84
Self-reported disease specific assessment of quality of life
Time frame: Day 0 and Day 28
Recruitment rates
Time frame: 1 year
Consent rate
Time frame: 1 year
Retention rate
Time frame: Day 0 to 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aloysius N Siriwardena, MBBS, PhD principal investigator
University of Lincoln
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MonitorMe in people with Chronic Obstructive Pulmonary Disease, run by University of Lincoln at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Saturation (time frame: Day 0 to 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024; AzTrials last refreshed its copy on 3 Nov 2026.