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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Control of respiratory failure defined by daytime partial pressure of carbon dioxide (PaCO2)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Control of respiratory failure defined by daytime partial pressure of carbon dioxide (PaCO2)
时间窗: 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.
时间窗: measured at 4 weeks since starting NIV
Semi-structured interview with patients and their carers
次要结局
- Cost effectiveness(Up to 7 months from initiation of NIV)
- NIV concordance(1 , 4 and 7 months)
- Quality of sleep(1,4,7 ,months)
- Satisfaction with NIV and healthcare interactions(7 months)
- Survival(Survival since NIV initiation)
- NIV acceptance(1 month)
- Admissions(Up to 7 months from initiation of NIV)
- NIV setting changes(1 , 4 and 7 months)
- Other blood gas analysis measurements of hypoventilation(1,4,7 months)
- Quality of life assessment (EQ-5D-5L)(1,4,7 ,months)
- Nocturnal oximetry(1,4,7 months)
- Quality of life (SRI)(1,4, 7 months)