EncoreAnywhere Use in Motor Neurone Disease

NCT03154450 | Completed DMC

• 1 other identifier: STH19228
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Adherence to non-invasive ventilation (NIV)

  Adherence to NIV at 3 months as defined by the use of NIV for a minimum of 28 hours per week (an average of 4 hours per day).

  One week

Secondary Outcomes (1)

• Effectiveness of non-invasive ventilation (NIV)

  3 months

Study Arms (2)

Data available to team

EXPERIMENTAL

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

Device: EncoreAnywhere with data available to review

No Data available to team

ACTIVE COMPARATOR

Encore Anywhere will be installed but the data collected will not be available to the clinical team

Device: EncoreAnywhere with no data available to review

Interventions

EncoreAnywhere with data available to review DEVICE

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

Data available to team

EncoreAnywhere with no data available to review DEVICE

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

No Data available to team

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with motor neuron disease diagnosed by a consultant neurologist.
• Receiving care from the Sheffield Teaching Hospitals NHS Trust MND clinic
• Respiratory failure diagnosed by the clinical team needing to start NIV
• Determined to be suitable for and willing to commence non-invasive ventilation including the EncoreAnywhere features as part of their usual care at the Royal Hallamshire Hospital MND clinic.

You may not qualify if:

• Patients already established on non-invasive ventilation e.g. in obstructive sleep apnoea
• Those with no mobile internet reception in their homes (required to use EncoreAnywhere

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Motor Neuron Disease

Condition Hierarchy (Ancestors)

Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Chris McDermott

  Sheffield Teaching Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 16, 2017
• Study Start: January 21, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: December 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)