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EncoreAnywhere Use in Motor Neurone Disease

NCT03154450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-12-04

No results posted yet for this study

Summary

Motor neurone disease is a progressive incurable disease causing weakness and paralysis of muscles. Respiratory failure is the most common cause of death in motor neurone disease. Patients with respiratory failure use a machine that supports breathing using a mask and ventilator (non-invasive ventilation: NIV) and using it for more than five hours per night has been shown to prolong life and improve symptoms such as poor sleep and breathlessness. NIV is however, challenging to use and some patients are unable to adhere to the required regime meaning they fail to gain benefit. Timely support is important to help individuals overcome early hurdles and barriers to using becoming regular NIV users.

The Philips EncoreAnywhere is a system that allows continuous monitoring of the use and effectiveness of ventilation and allows instant adjustment of ventilator settings. The aim of this project is to explore if "real time" feedback and support, as well as remote changes to NIV settings using the EncoreAnywhere system could increase the number of individuals successfully using NIV. This project also aims to explore the impact of using EncoreAnywhere on the process of initiation of NIV, on both patients and staff.

Patients starting NIV at the Sheffield MND care centre will be provided with the standard ventilator plus a Philips modem for the first three months of use. In half the patients clinicians will be able to use the EncoreAnywhere system to review patients' use of NIV, make adjustments and give feedback. In the other half, the data will be collected but not available to the clinical team. Clinical data will be collected as part of usual care: adherence, clinical encounters and resource use and patients will be asked to complete questionnaires at baseline, one month and three months. This will allow the care team to predict the potential impact on the service and on clinical care. This is a small pilot, feasibility study, and if the study is deemed feasible, a further larger randomized controlled trial is planned. The study will last for a maximum of 12 months, recruiting up to 40 patients.

Conditions

  • Motor Neuron Disease

Interventions

DEVICE

EncoreAnywhere with data available to review

Encore Anywhere will be installed and available for review by the clinical team

DEVICE

EncoreAnywhere with no data available to review

Encore Anywhere will be installed but not available for review by the clinical team

Sponsors & Collaborators

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Chris McDermott · Sheffield Teaching Hospitals NHS FT

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-21
Primary Completion
2017-04-01
Completion
2017-04-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03154450 on ClinicalTrials.gov