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Use of MonitorMe in COPD

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ClinicalTrials.gov Identifier: NCT04108143
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : April 27, 2021
Sponsor:
Collaborators:
Sanandco Ltd
National Health Service, United Kingdom
Information provided by (Responsible Party):
University of Lincoln

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: MonitorMe Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Use of MonitorMe in COPD: a Mixed-methods Feasibility Study
Actual Study Start Date : February 11, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2021

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.




Primary Outcome Measures :
  1. Oxygen Saturation [ Time Frame: Day 0 to 28 ]
    Agreement between measurements made by MonitorMe and healthcare professionals


Secondary Outcome Measures :
  1. Temperature [ Time Frame: Day 0 to 28 ]
    Agreement between measurements made by MonitorMe and healthcare professionals

  2. Heart rate/pulse rate [ Time Frame: Day 0 to 28 ]
    Agreement between measurements made by MonitorMe and healthcare professionals

  3. Adverse event rate [ Time Frame: Day 0 to 28 ]
    Number of reported adverse events during study period

  4. Patient compliance [ Time Frame: Day 0 to 28 ]
    Number of MonitorMe automated calls completed during observation period

  5. Usability [ Time Frame: Day 0 to 28 ]
    Number of unsuccessful data transmissions or missing data (confidence values of MonitorMe)

  6. Acceptance/experience of MonitorMe for patients [ Time Frame: Day 28 to 84 ]
    Semi-structured interviews

  7. Acceptance/experience of MonitorMe for health care professionals [ Time Frame: Day 28 to 84 ]
    Semi-structured interviews

  8. Self-reported disease specific assessment of quality of life [ Time Frame: Day 0 and Day 28 ]
    Chronic Respiratory Questionnaire

  9. Recruitment rates [ Time Frame: 1 year ]
    Time taken to achieve planned sample size

  10. Consent rate [ Time Frame: 1 year ]
    Number of eligible patients willing to consent to take part in the study

  11. Retention rate [ Time Frame: Day 0 to 28 ]
    Number of patients who complete the study



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Ages Eligible for Study:   40 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04108143


Contacts
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Contact: Aloysius N Siriwardena, MBBS, PhD +44 (0)1522 886939 nsiriwardena@lincoln.ac.uk
Contact: Arwel W Jones, PhD +44 (0)1522 886451 arjones@lincoln.ac.uk

Locations
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United Kingdom
University of Lincoln Recruiting
Lincoln, United Kingdom, LN6 7TS
Contact: Arwel W Jones, PhD       arjones@lincoln.ac.uk   
Lincolnshire Community Health Services NHS Trust Recruiting
Lincoln, United Kingdom
Contact: Debbie Jeffrey       debbiedebbie.jeffrey@nhs.net   
Sponsors and Collaborators
University of Lincoln
Sanandco Ltd
National Health Service, United Kingdom
Investigators
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Principal Investigator: Aloysius N Siriwardena, MBBS, PhD University of Lincoln
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Responsible Party: University of Lincoln
ClinicalTrials.gov Identifier: NCT04108143    
Other Study ID Numbers: 181003
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Lincoln:
Telehealth
Telemonitoring
COPD
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases