RecruitingNAINTERVENTIONAL

Home Versus Hospital Based NIV Care in MND

This study explores whether people with Motor Neurone Disease (MND) who need breathing support (called Non-invasive ventilation or NIV) can start and manage this treatment effectively at home, instead of in the hospital. NIV helps with breathing difficulties and can improve quality of life and potentially extend life for MND patients. For those who struggle with hospital visits due to their condition, starting NIV at home could be more convenient. Researchers will compare home-based care (with home visits and remote monitoring) against hospital-based care. They will look at how well the treatment works, patient and caregiver experiences, quality of life, and cost-effectiveness. The goal is to develop a patient-friendly NIV service for the future.

At a glance

Status

Recruiting

Phase

Sponsor

Papworth Hospital NHS Foundation Trust

Enrolment target

Start

06 Mar 2024

Estimated completion

01 Sep 2026

Motor Neurone Disease Respiratory Insufficiency

What is this study about?

Many people with Motor Neurone Disease (MND) eventually experience breathing difficulties. A treatment called Non-invasive ventilation, or NIV, can help with this. NIV uses a mask and a machine to support your breathing, especially at night. It's known to significantly improve how people feel and can even help them live longer. Traditionally, starting NIV treatment often involves a stay in the hospital, where you learn how to use the equipment and get the settings just right. However, travelling to and from the hospital can become very challenging for people with MND as their condition progresses and they may need wheelchairs or have other health concerns.

This study is investigating whether setting up and monitoring NIV at home could be a good and safe alternative for some people. While home treatment might be much more convenient, setting up NIV is quite a detailed process, and it's important to make sure home-based care is just as safe and works just as well as hospital-based care.

To find this out, 60 patients with MND who need NIV will take part. They will be randomly assigned to either receive their NIV setup and ongoing care at home (with home visits and support through technology) or in the hospital (with an initial hospital stay and then outpatient appointments). The study will look at how effective the treatment is, how patients and their carers feel about the different approaches, how it affects their quality of life, and the financial aspects. We're hoping the results will help us understand the best ways to provide NIV care for people with MND in the future.

Key takeaways

A study comparing starting breathing support (NIV) at home versus in hospital for MND patients.
Aims to find out if home-based NIV is as safe and effective, and more convenient.
Participants will be randomly assigned to home or hospital care groups.
The study includes check-ups at 1, 4, and 7 months.
It also explores patient and carer experiences with NIV.
Findings will help improve future NIV services for MND.

Who may be eligible?

To be part of this study, you would need to be an adult who has been formally diagnosed with Motor Neurone Disease by a specialist doctor. You would also need to be at a stage where your doctors recommend NIV because you're showing signs of breathing difficulties, such as tiredness in the mornings, waking up feeling breathless, or needing to sit upright to breathe comfortably, and specific breathing tests confirm your breathing muscles are weak.

There are certain situations where you wouldn't be able to join the study. For example, if you have memory or thinking problems that make it hard to understand what's involved, or if you have other serious health conditions like severe heart problems, lung disease (like severe COPD), or severe obesity that could also be causing breathing issues. If you need to start NIV very urgently (within 24 hours) or are unwell with something else requiring hospital treatment (like a serious infection), you wouldn't be eligible right now. Finally, if you don't have enough support at home to manage home NIV, or simply don't wish to try home NIV, then this study wouldn't be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a confirmed diagnosis of Motor Neurone Disease from a specialist?
Am I experiencing breathing difficulties or showing signs my doctor recommends NIV?
Do I understand and feel comfortable with the idea of taking part in a research study?
Do I have enough support at home if I were to be in the home NIV group?
Do I need to start breathing support very urgently (within 24 hours)?
Do I have other serious health problems that affect my breathing, like very severe heart or lung disease?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to one of two groups: either you'll start your breathing support (NIV) at home, with nurses visiting you and doctors monitoring you remotely, or you'll go to the hospital to have your NIV set up, followed by hospital outpatient appointments for monitoring. Regardless of your group, you'll have check-ups at 1 month, 4 months, and 7 months after starting NIV. These check-ups will involve assessments of how well the treatment is working, how it impacts your quality of life, and your and your carer's preferences. There are no specific medications involved in this study; it's about how the NIV support is delivered. Some participants and their carers will also be invited for an interview to share their experiences in more detail.

Potential risks and benefits

Participating in this study might offer the benefit of receiving your NIV treatment in a way that is more convenient for you, potentially reducing hospital visits. The study aims to ensure that home-based care is as safe and effective as hospital-based care. As with any medical intervention, there could be unforeseen risks associated with either approach, but both methods are established ways of providing NIV. You are always free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Paworth Hospital
Verified postcode
Cambridge, United Kingdom· Recruiting

Common questions

What is NIV?

NIV stands for Non-invasive ventilation. It's a type of breathing support that uses a mask (worn over your nose or nose and mouth) and a machine to help you breathe, usually during sleep, if you have breathing difficulties.

Will I have to pay for anything?

No, you will not have to pay for any part of your participation in this study, including the NIV equipment or any appointments related to the study.

How long will the study last for me?

If you take part, you will be followed up for a total of 7 months after you start your breathing support (NIV).

Will I get to choose if I start NIV at home or in hospital?

No, participants will be randomly assigned to either the home-based or hospital-based NIV group, like flipping a coin, to ensure fairness and good scientific results.

Will my regular MND care change if I join the study?

Your regular MND care will continue as usual. This study focuses specifically on how your NIV breathing support is started and monitored, not your overall MND treatment plan.

How to find out more

Dariusz Wozniak

dariusz.wozniak@nhs.net 01223639619 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.