A trial to improve delivery of non-invasive ventilation
MND can cause breathing problems which can be helped by using non-invasive ventilation (NIV). NIV is delivered using a portable ventilator and a mask. Although it is very effective, many people with MND still struggle to use NIV.
Telemonitoring in NIV is a way for healthcare teams to remotely access information from ventilators to check things are working well. Very few hospitals are currently using telemonitoring in NIV. The researchers have created a plan which could help healthcare teams provide better NIV support for people with MND, using telemonitoring. They wish to test this plan against the current standard of care, to understand if it does deliver better NIV support.
In this study, the researchers will compare two groups – people receiving their usual respiratory care and people who receive additional telemonitoring support. They will also look at what happens within the hospitals and whether healthcare professionals are able to adopt the new approach, and how it fits into NHS services.
For more information about the DENIM trial, visit the trial website.
Taking Part
What does taking part involve?
Before taking part in the study, one of the researchers may get in touch to ask you some questions to confirm your suitability for the trial, and answer any questions you may have. If you choose to take part, you will be asked to sign a consent form, and answer some questions about your symptoms and quality of life. You will be randomly assigned to either the control group or the intervention group.
Participants in the control group will continue with their usual respiratory care. In the intervention group, the care team will receive extra training on setting up and supporting NIV. When participants start NIV, the care team will assess anything which might make NIV harder for them and discuss treatment goals, before setting up the ventilator and showing them how to use it. Once participants are using the ventilator at home, the care team will use telemonitoring to check how the ventilator is working. The team will contact participants in the intervention group frequently, at set times and whenever anything needs adjusting. The team can provide advice and support and make necessary changes to ventilator settings remotely.
The study will last 12 weeks. Researchers will access anonymous information from participants’ ventilators over the 12 weeks. Participants will also complete questionnaires about breathing symptoms and quality of life at the start and end of the study. Participants can also choose to take part in an optional interview about their NIV experience.
Information about the trial is also available in other languages.
Who can take part?
People with MND who:
• Are over 18
• Are starting NIV at one of the 12 UK sites taking part in the study.
The 12 UK sites taking part in the study are:
• Sheffield Teaching Hospitals NHS Foundation Trust
• Newcastle Hospitals NHS Foundation Trust
• Lane Fox Respiratory Service (Guy's & St Thomas' NHS Foundation Trust)
• Salford Royal (Manchester)
• University Hospitals of Leicester NHS Foundation Trust
• University Hospital Oxford
• Barts Health NHS Trust
• St George’s University Hospitals NHS Foundation Trust
• Norfolk and Norwich NHS Foundation Trust
• Leeds Teaching Hospital NHS Foundation Trust
• University Hospital North Midlands
• University Hospital Nottingham
People who choose not to take part in the study will be invited to take part in a short interview to tell the researchers about their experiences.
How can I take part?
If you are interested in taking part in this trial, or have any further questions, then please contact your MND or respiratory care team
Study location
UK-wide
Funding
This study is funded by National Institute for Health Research (NIHR) Health and Social Care Delivery Research (HSDR)