EncoreAnywhere Use in Motor Neurone Disease

Monitoring and Promoting Effectiveness and Adherence to Non-invasive Ventilation in Motor Neurone Disease Using EncoreAnywhere Telemonitoring.

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.

Study Overview

• Status: Completed
• Conditions: Motor Neuron Disease
• Intervention / Treatment: Device: EncoreAnywhere with data available to review; Device: EncoreAnywhere with no data available to review

Detailed Description

Non-invasive ventilation (NIV) use in patients with motor neurone disease (MND) who develop respiratory failure can improve symptoms and survival. Initiation of NIV can be difficult for patients and those who do not adequately adhere to the regime fail to gain benefit. This study will evaluate the use of EncoreAnywhere: a system which collects data on NIV use and effectiveness from the NIV machines and transmits it to the MND care team for review.

This study is a pilot, feasibility study. It is a randomised controlled trial comparing the use of EncoreAnywhere with usual care. Up to 40 patients with MND about to start NIV will be recruited. All patients will have the EncoreAnywhere system installed on their NIV machine for the first three months of NIV use. Half the patients will be randomised to the intervention arm which will allow the MND care team to review the information sent from the device regularly during the study. Data will be collected from the other patients but not reviewed by the clinical team. All patients will receive usual care.

Data will be collected by three methods. Data collected from the EncoreAnywhere system will examine adherence and effectiveness of ventilation. The main outcome of interest is adherence to NIV at three months. Data will be collected from patients (patient symptoms and quality of life) using questionnaires (at baseline, one and three months) and collected from information recorded in the patients' notes as part of usual care. Data will also be collected to examine feasibility e.g. recruitment and retention rates. A subset of patients will be invited to undergo overnight oximetry at 1 and 3 months to examine NIV effectiveness.

The aims of the research are to establish the level of adherence and effectiveness of NIV during initiation and factors that may impact on adherence and effectiveness and also evaluate the feasibility and impact using EncoreAnywhere on the Sheffield MND team working pattern, the clinical and cost implications for a full service.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2JF
      • Royal Hallamshire Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with motor neuron disease diagnosed by a consultant neurologist.
2. Receiving care from the Sheffield Teaching Hospitals NHS Trust MND clinic
3. Respiratory failure diagnosed by the clinical team needing to start NIV
4. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Data available to team; Encore Anywhere will be installed and available for review by the clinical team	Device: EncoreAnywhere with data available to review; Encore Anywhere will be installed and available for review by the clinical team
ACTIVE_COMPARATOR: No Data available to team; 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; Encore Anywhere will be installed but not available for review by the clinical team

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of non-invasive ventilation (NIV)	Number of episodes of leak or obstruction and Patient satisfaction/perception of service delivery	3 months

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Chris McDermott, Sheffield Teaching Hospitals NHS FT

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 21, 2016
• Primary Completion (ACTUAL): April 1, 2017
• Study Completion (ACTUAL): April 1, 2017

Study Registration Dates

• First Submitted: May 12, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (ACTUAL): May 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 4, 2017
• Last Update Submitted That Met QC Criteria: December 1, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: STH19228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No