Clinical trial NCT06844370: Home Versus Hospital Based NIV Care in MND
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Motor Neurone Disease
Respiratory Insufficiency
Keywords: non invasive ventilation
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Nottingham
name: MND Association
First posted: 2025-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random allocation to either home or hospital based treatment
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Adults with a diagnosis of Motor Neurone Disease confirmed by a neurologist specialising in MND.
* Indications to NIV: daytime pCO2 \>6.0 kPa or/and symptoms of ventilatory failure (e.g. orthopnoea, paroxysmal nocturnal dyspnoea, morning drowsiness) in the presence of significant diaphragmatic weakness confirmed by respiratory muscle tests

Exclusion Criteria:

* Cognitive impairment precluding understanding of the study protocol and valid consent
* Severe co-morbidities (e.g. decompensated heart failure, severe chronic obstructive pulmonary disease (COPD), morbid obesity) causing or contributing to respiratory failure
* Immediate need to start NIV (\<24hrs) and/or acute illness requiring inpatient treatment e.g. intravenous antibiotics for pneumonia (in addition to the need for NIV)
* Lack of a sufficient social/professional network to support NIV application at home
* Not wishing to accept home NIV

Primary outcomes:
measure: Control of respiratory failure defined by daytime partial pressure of carbon dioxide (PaCO2)
timeFrame: measured at 1,4,7 months following NIV initiation
measure: Patients and carers experiences of starting and managing NIV, and factors that relate to NIV concordance and acceptance.
timeFrame: measured at 4 weeks since starting NIV
Secondary outcomes:
measure: NIV acceptance
timeFrame: 1 month
measure: NIV concordance
timeFrame: 1 , 4 and 7 months
measure: Survival
timeFrame: Survival since NIV initiation
measure: Admissions
timeFrame: Up to 7 months from initiation of NIV
measure: NIV setting changes
timeFrame: 1 , 4 and 7 months
measure: Cost effectiveness
timeFrame: Up to 7 months from initiation of NIV
measure: Nocturnal oximetry
timeFrame: 1,4,7 months
measure: Other blood gas analysis measurements of hypoventilation
timeFrame: 1,4,7 months
measure: Quality of life assessment (EQ-5D-5L)
timeFrame: 1,4,7 ,months
measure: Quality of life (SRI)
timeFrame: 1,4, 7 months
measure: Quality of sleep
timeFrame: 1,4,7 ,months
measure: Satisfaction with NIV and healthcare interactions
timeFrame: 7 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Royal Paworth Hospital
Study officials:
affiliation: Royal Papworth Hospital NHS Foundation Trust
name: Dariusz Wozniak
role: PRINCIPAL_INVESTIGATOR
References: