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DENIM Study Protocol v1.1
2025-02-12_DENIM Protocol v1.1_clean.pdfMND and NIV
Motor Neuron disease (MND) is a neurological disorder that affects 1 in 300 people and has no known cure. As MND progresses, it causes a weakness in the muscles that control breathing, resulting in an incapacity to breathe without medical support. This can be helped by using non-invasive ventilation (NIV).
NIV is the only treatment shown to help people with MND live longer. NIV involves wearing a mask over the face to support breathing and many people find it hard to use. This means around more than half of people are not getting the full benefits, either because they are unable to use it for long enough or because it does not work well. This means people with MND feel worse and die sooner than they need to.
You can find out more about NIV here: www.mybreathing.mymnd.org.uk
Not every NHS service delivers NIV support in the same way and there are lots of reasons why this is. DENIM hopes to change the way NHS teams deliver 'optimised' NIV support through a new intensive NIV initiation service and the use of telemonitoring. We will then measure if this is successful by assessing NIV use and participant and staff experiences.
DENIM aims
The aim of this research is to evaluate the effectiveness of the DENIM implementation strategy, which is a new intensive NIV initiation service for patients with motor neuron disease.
The secondary aim is to assess the impact of the DENIM strategy on clinical outcomes for these patients, including the use and effectiveness of NIV. DENIM also aims to understand the cost-effectiveness of the new intensive NIV initiation service and explore contextual barriers to normalising such a service within routine clinical practice.
What will happen?
Over 250 people with MND who are starting NIV will take part in the study. Each person will be involved for the first 12 weeks after starting NIV. All patients will receive the usual care from their healthcare team, but half will also receive additional support.
The healthcare team will get extra training to help them understand MND and NIV better and to support the patient and their family to adapt to using NIV. They will receive additional time and extra information sent automatically from the NIV machine in the patient’s home (called telemonitoring). This tells staff if there are problems with the NIV without patients having to remember, and specialists can make changes more quickly. Extra support will be given to ensure we meet everybody's different accessibility needs.
How does DENIM involve people living with MND?
We have worked alongside the Sheffield MND Research Advisory Group (Sheffield MND RAG) whose top priority is to improve care for people living with MND whilst they wait for a cure, emphasising that breathing support is a key part of this.
You can find out more about the Sheffield MND RAG here: www.smndrag.sites.sheffield.ac.uk
A range of people with lived experiences of MND including patients, carers, family members, and peer supporters have played a key role in the design and conduct of our research. They co-designed the website www.mybreathing.mymnd.org.uk to help people with MND learn about NIV. They have provided us with invaluable advice throughout the study development process.
Two of our research collaborators have lived experiences of MND and together we have formed an advisory group that meets regularly to advise on all aspects of the study.
See our patient and public involvement and engagement (PPIE) page for more information.
Disclaimer: The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
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