Motor Neuron DiseaseNCT03154450
EncoreAnywhere Use in Motor Neurone Disease
A study testing EncoreAnywhere with data available to review and EncoreAnywhere with no data available to review in people with Motor Neuron Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Motor Neuron Disease
- What is being tested?
- EncoreAnywhere with data available to review and EncoreAnywhere with no data available to review
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jan 2016to 1 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: 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.
Read the 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.
- Conditions
- Motor Neuron Disease
- Being tested
- EncoreAnywhere with data available to review, EncoreAnywhere with no data available to review
- Medical subject headings
- Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EncoreAnywhere with data available to reviewDevice
Encore Anywhere will be installed and available for review by the clinical team
EncoreAnywhere with no data available to reviewDevice
Encore Anywhere will be installed but not available for review by the clinical team
| Study group | Role | What they receive |
|---|---|---|
| Data available to team | Experimental | Encore Anywhere will be installed and available for review by the clinical team Receives: 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 Receives: Device: EncoreAnywhere with no data available to review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: One week
Secondary outcomes (1)
Effectiveness of non-invasive ventilation (NIV)
Number of episodes of leak or obstruction and Patient satisfaction/perception of service delivery
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start21 Jan 2016
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Neuron DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris McDermott, Principal investigator, Sheffield Teaching Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154450
- Sponsor's protocol ID
- STH19228
- Status last verified
- May 2017
- First submitted
- 12 May 2017
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring and Promoting Effectiveness and Adherence to Non-invasive Ventilation in Motor Neurone Disease Using EncoreAnywhere Telemonitoring.
- ClinicalTrials.gov ID
- NCT03154450
- Acronym / sponsor ID
- STH19228
- Conditions
- Motor Neuron Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 21 Jan 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Data available to team | Experimental | Device: EncoreAnywhere with data available to reviewEncore Anywhere will be installed and available for review by the clinical team |
| No Data available to team | Active comparator | Device: EncoreAnywhere with no data available to reviewEncore Anywhere will be installed but the data collected will not be available to the clinical team |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EncoreAnywhere with data available to reviewEncore Anywhere will be installed and available for review by the clinical team | Device | Data available to team |
| EncoreAnywhere with no data available to reviewEncore Anywhere will be installed but not available for review by the clinical team | Device | No Data available to team |
Primary outcome
Adherence to non-invasive ventilation (NIV)
Time frame: One week
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).
1 secondary outcome
Effectiveness of non-invasive ventilation (NIV)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Individual participant dataSharing planned: No. no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris McDermott principal investigator
Sheffield Teaching Hospitals NHS FT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EncoreAnywhere with data available to review and EncoreAnywhere with no data available to review in people with Motor Neuron Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to non-invasive ventilation (NIV) (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2017.