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Recruiting NCT06844370

Home Versus Hospital Based NIV Care in MND

No phase Interventional Motor Neurone Disease Respiratory Insufficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-invasive ventilation.
Who it may be relevant to
Registry conditions: Motor Neurone Disease, Respiratory Insufficiency. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Other Non-invasive ventilation
    Providing ventilation support through non-invasive means

Primary outcome measures

  • Control of respiratory failure defined by daytime partial pressure of carbon dioxide (PaCO2) [Time frame: measured at 1,4,7 months following NIV initiation]
  • Patients and carers experiences of starting and managing NIV, and factors that relate to NIV concordance and acceptance. [Time frame: measured at 4 weeks since starting NIV]
Secondary outcome measures (12)
  • NIV acceptance [Time frame: 1 month]
  • NIV concordance [Time frame: 1 , 4 and 7 months]
  • Survival [Time frame: Survival since NIV initiation]
  • Admissions [Time frame: Up to 7 months from initiation of NIV]
  • NIV setting changes [Time frame: 1 , 4 and 7 months]
  • Cost effectiveness [Time frame: Up to 7 months from initiation of NIV]
  • Nocturnal oximetry [Time frame: 1,4,7 months]
  • Other blood gas analysis measurements of hypoventilation [Time frame: 1,4,7 months]
  • Quality of life assessment (EQ-5D-5L) [Time frame: 1,4,7 ,months]
  • Quality of life (SRI) [Time frame: 1,4, 7 months]
  • Quality of sleep [Time frame: 1,4,7 ,months]
  • Satisfaction with NIV and healthcare interactions [Time frame: 7 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • Royal Paworth Hospital — Cambridge

Identifiers

NCT: NCT06844370 · P03084

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗