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| Name | Class |
|---|---|
| Sanandco Ltd | UNKNOWN |
| National Health Service, United Kingdom | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | MonitorMe device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MonitorMe | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Saturation | Agreement between measurements made by MonitorMe and healthcare professionals | Day 0 to 28 |
| 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 |
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Inclusion Criteria:
Patients
Health care professionals
Exclusion Criteria:
Patients
Health care professionals
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| Name | Affiliation | Role |
|---|---|---|
| Aloysius N Siriwardena, MBBS, PhD | University of Lincoln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Lincoln | Lincoln | LN6 7TS | United Kingdom | |||
| Lincolnshire Community Health Services NHS Trust |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
| 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 |
| Lincoln |
| United Kingdom |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |