NCT06844370

Home Versus Hospital Based NIV Care in MND

Home Initiation and Monitoring of Non-invasive Ventilation (NIV) Versus Hospital-based Care in People with Motor Neurone Disease (MND) : a Randomised Control Trial (RCT) and Qualitative Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Papworth Hospital NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Non-invasive ventilation (NIV) is commonly offered to people with Motor Neurone Disease (MND) who have breathing difficulties. It improves their quality of life and can prolong life by 6 months or more. It is initially used at night and typically set up during a hospital admission. By the time that they develop respiratory failure and need to start NIV, however, most patients require wheelchairs or have other significant health problems. Repeated travel to hospitals is increasingly difficult with increasing disability. It is possible to start and monitor NIV treatment at home. This may be more convenient for selected patients, though starting NIV is quite complex; it is not known if home treatment is as safe and effective as hospital-based treatment. To establish this, 60 patients with MND who have indications for NIV will be recruited. They will be randomly allocated to a home-based treatment (home NIV set up plus home visits supported by telemonitoring) or hospital-based care (inpatient NIV set up plus outpatient NIV monitoring) and followed up at 1, 4 and 7 months. Alongside measures of treatment effectiveness, assessment of patient and carer preferences, quality of life, and cost-effectiveness will be undertaken. In the additional qualitative part on this study, interviews with patients who took part in the main study and their carers will be conducted to understand in more depth their perspective on what makes for a good or bad experience with NIV, how the environment (home vs hospital) influences their NIV experience and what personal factors determine NIV use. Findings from the interviews will inform the design of a truly patient-centred NIV service.

Conditions

• Motor Neurone Disease
• Respiratory Insufficiency

Interventions

Type	Name	Description
OTHER	Non-invasive ventilation	Providing ventilation support through non-invasive means

Timeline

• Start date: 2024-03-06
• Primary completion: 2026-02-01
• Completion: 2026-09-01
• First posted: 2025-02-25
• Last updated: 2025-02-25

Locations

1 site across 1 country: United Kingdom