- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04108143
Use of MonitorMe in COPD
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.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Lincoln, Reino Unido, LN6 7TS
- University of Lincoln
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Lincoln, Reino Unido
- Lincolnshire Community Health Services NHS Trust
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Intervention
MonitorMe device
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Oxygen Saturation
Periodo de tiempo: Day 0 to 28
|
Agreement between measurements made by MonitorMe and healthcare professionals
|
Day 0 to 28
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Temperature
Periodo de tiempo: Day 0 to 28
|
Agreement between measurements made by MonitorMe and healthcare professionals
|
Day 0 to 28
|
Heart rate/pulse rate
Periodo de tiempo: Day 0 to 28
|
Agreement between measurements made by MonitorMe and healthcare professionals
|
Day 0 to 28
|
Adverse event rate
Periodo de tiempo: Day 0 to 28
|
Number of reported adverse events during study period
|
Day 0 to 28
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Patient compliance
Periodo de tiempo: Day 0 to 28
|
Number of MonitorMe automated calls completed during observation period
|
Day 0 to 28
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Usability
Periodo de tiempo: Day 0 to 28
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Number of unsuccessful data transmissions or missing data (confidence values of MonitorMe)
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Day 0 to 28
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Acceptance/experience of MonitorMe for patients
Periodo de tiempo: Day 28 to 84
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Semi-structured interviews
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Day 28 to 84
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Acceptance/experience of MonitorMe for health care professionals
Periodo de tiempo: Day 28 to 84
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Semi-structured interviews
|
Day 28 to 84
|
Self-reported disease specific assessment of quality of life
Periodo de tiempo: Day 0 and Day 28
|
Chronic Respiratory Questionnaire
|
Day 0 and Day 28
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Recruitment rates
Periodo de tiempo: 1 year
|
Time taken to achieve planned sample size
|
1 year
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Consent rate
Periodo de tiempo: 1 year
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Number of eligible patients willing to consent to take part in the study
|
1 year
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Retention rate
Periodo de tiempo: Day 0 to 28
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Number of patients who complete the study
|
Day 0 to 28
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Aloysius N Siriwardena, MBBS, PhD, University of Lincoln
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 181003
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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