Clinical trial NCT04108143: Use of MonitorMe in COPD
Official title: Use of MonitorMe in COPD: a Mixed-methods Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Telehealth
Telemonitoring
COPD
Lead sponsor: University of Lincoln
Sponsor class: OTHER
Collaborators: name: Sanandco Ltd
name: National Health Service, United Kingdom
First posted: 2019-09-27
Enrollment: 13
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Oxygen Saturation
timeFrame: Day 0 to 28
Secondary outcomes:
measure: Temperature
timeFrame: Day 0 to 28
measure: Heart rate/pulse rate
timeFrame: Day 0 to 28
measure: Adverse event rate
timeFrame: Day 0 to 28
measure: Patient compliance
timeFrame: Day 0 to 28
measure: Usability
timeFrame: Day 0 to 28
measure: Acceptance/experience of MonitorMe for patients
timeFrame: Day 28 to 84
measure: Acceptance/experience of MonitorMe for health care professionals
timeFrame: Day 28 to 84
measure: Self-reported disease specific assessment of quality of life
timeFrame: Day 0 and Day 28
measure: Recruitment rates
timeFrame: 1 year
measure: Consent rate
timeFrame: 1 year
measure: Retention rate
timeFrame: Day 0 to 28
Other outcomes:
Locations:
city: Lincoln
country: United Kingdom
facility: University of Lincoln
city: Lincoln
country: United Kingdom
facility: Lincolnshire Community Health Services NHS Trust
Study officials:
affiliation: University of Lincoln
name: Aloysius N Siriwardena, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: