Home Versus Hospital Based NIV Care in MND

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Control of respiratory failure defined by daytime partial pressure of carbon dioxide (PaCO2) [Срок оценки: 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. [Срок оценки: measured at 4 weeks since starting NIV]

Вторичные конечные точки (12)

• NIV acceptance [Срок оценки: 1 month]
• NIV concordance [Срок оценки: 1 , 4 and 7 months]
• Survival [Срок оценки: Survival since NIV initiation]
• Admissions [Срок оценки: Up to 7 months from initiation of NIV]
• NIV setting changes [Срок оценки: 1 , 4 and 7 months]
• Cost effectiveness [Срок оценки: Up to 7 months from initiation of NIV]
• Nocturnal oximetry [Срок оценки: 1,4,7 months]
• Other blood gas analysis measurements of hypoventilation [Срок оценки: 1,4,7 months]
• Quality of life assessment (EQ-5D-5L) [Срок оценки: 1,4,7 ,months]
• Quality of life (SRI) [Срок оценки: 1,4, 7 months]
• Quality of sleep [Срок оценки: 1,4,7 ,months]
• Satisfaction with NIV and healthcare interactions [Срок оценки: 7 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• Royal Paworth Hospital — Cambridge

Идентификаторы

NCT: NCT06844370 · P03084

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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