Home Versus Hospital Based NIV Care in MND

Not Applicable

Recruiting

• Conditions: Motor Neurone Disease; Respiratory Insufficiency

• Registration Number: NCT06844370
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-06
• Study First Submitted: 2024-03-14
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25
• Primary Completion: 2026-02
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Control of respiratory failure defined by daytime partial pressure of carbon dioxide (PaCO2)	measured at 1,4,7 months following NIV initiation	Daytime PaCO2 measured by arterial puncture
Patients and carers experiences of starting and managing NIV, and factors that relate to NIV concordance and acceptance.	measured at 4 weeks since starting NIV	Semi-structured interview with patients and their carers

Secondary Outcome Measures

Name	Time	Method
Cost effectiveness	Up to 7 months from initiation of NIV	Absolute costs and costs in relation to quality-adjusted life-years (using EQ-5D)
NIV concordance	1 , 4 and 7 months	NIV adherence (machine usage in hours/24hours)
Quality of sleep	1,4,7 ,months	Sleep quality measured with Pittsburgh Sleep Quality Index (PSQI)
Satisfaction with NIV and healthcare interactions	7 months	Satisfaction with NIV and healthcare interactions measured with a visual analogue scale
Survival	Survival since NIV initiation	Survival (in months)
NIV acceptance	1 month	Percent of patients using NIV for \>=4hrs/night
Admissions	Up to 7 months from initiation of NIV	Number of additional planned and emergency hospital admissions
NIV setting changes	1 , 4 and 7 months	Number of NIV setting changes required
Other blood gas analysis measurements of hypoventilation	1,4,7 months	Bicarbonate
Quality of life assessment (EQ-5D-5L)	1,4,7 ,months	Measurement of quality of life using EQ-5D-5L questionnaire
Nocturnal oximetry	1,4,7 months	time spent with oxygen saturation \<90%(TST90)
Quality of life (SRI)	1,4, 7 months	Quality of life measured using Severe Respiratory Insufficiency (SRI) questionnaire

Trial Locations

Locations (1)

Royal Paworth Hospital; 🇬🇧 Cambridge, United Kingdom