Home Versus Hospital Based NIV Care in MND

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-06

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Motor Neurone Disease Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Random allocation to either home or hospital based treatment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home initiation of NIV

Initiation of NIV at home and follow up by home visits and telemonitoring

Group Type OTHER

Non-invasive ventilation

Intervention Type OTHER

Providing ventilation support through non-invasive means

Hospital initiation of NIV

Initiation of NIV at hospital with monitoring at outpatient visits

Group Type OTHER

Non-invasive ventilation

Intervention Type OTHER

Providing ventilation support through non-invasive means

Interventions

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Non-invasive ventilation

Providing ventilation support through non-invasive means

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No