Use of MonitorMe in COPD

Study Overview
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Brief Summary
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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.

Official Title
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Use of MonitorMe in COPD: a Mixed-methods Feasibility Study

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: MonitorMe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>MonitorMe device | Device: MonitorMe<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Saturation | Agreement between measurements made by MonitorMe and healthcare professionals | Day 0 to 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature | Agreement between measurements made by MonitorMe and healthcare professionals | Day 0 to 28 | 
| Heart rate/pulse rate | Agreement between measurements made by MonitorMe and healthcare professionals | Day 0 to 28 | 
| Adverse event rate | Number of reported adverse events during study period | Day 0 to 28 | 
| Patient compliance | Number of MonitorMe automated calls completed during observation period | Day 0 to 28 | 
| Usability | Number of unsuccessful data transmissions or missing data (confidence values of MonitorMe) | Day 0 to 28 | 
| Acceptance/experience of MonitorMe for patients | Semi-structured interviews | Day 28 to 84 | 
| Acceptance/experience of MonitorMe for health care professionals | Semi-structured interviews | Day 28 to 84 | 
| Self-reported disease specific assessment of quality of life | Chronic Respiratory Questionnaire | Day 0 and Day 28 | 
| Recruitment rates | Time taken to achieve planned sample size | 1 year | 
| Consent rate | Number of eligible patients willing to consent to take part in the study | 1 year | 
| Retention rate | Number of patients who complete the study | Day 0 to 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telehealth, Telemonitoring, COPD