Optimising the Management of Ventilated Patients and Quality of Life in Motor Neurone Disease: a Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 主要终点
- Acceptability - Qualitative data through semi-structured interviews and focus groups
研究概览
简要总结
This is a feasibility study of telemonitoring system for people with MND/ALS, who are on NIV, via a call centre operated by a local clinical commissioning group.
详细描述
This study will test the feasibility of previously developed Telehealth system, using a device called Careportal®, to monitor people with MND/ALS who are using non-invasive ventilation (NIV). The Careportal® is a CE marked portable tablet computer device allowing telecommunication between patients and their care team through bespoke question sets, overnight oximetry test, and patient-ventilator interaction(PVI) data. Previously, the weekly telemonitoring via Careportal® was found to be an effective method to monitor symptom changes, allowing clinicians to optimise the care of ventilated patients with MND. This study will assess the practicality of using Careportal® in the care of ventilated patients with MND by monitoring patients through a patient support call centre. The call centre will screen the data and liaise with appropriate clinicians regarding changes of symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Acceptability - Qualitative data through semi-structured interviews and focus groups
时间窗: Qualitative data will be conducted at 3-month
Qualitative data will be collected through focus groups with participants, their lay caregivers, and clinicians. Separate focus groups will be conducted for the three participant groups with an option of individual interviews for patients and lay caregivers.
Usability - Qualitative data through semi-structured interviews and focus groups
时间窗: Qualitative data will be conducted at 3-month
Qualitative data will be collected through focus groups with participants, their lay caregivers, and clinicians. Separate focus groups will be conducted for the three participant groups with an option of individual interviews for patients and lay caregivers.
次要结局
- Patient Reported Outcome Measurement - revised Amyotrophic Lateral Sclerosis Functional Rating Scale(Baseline and at 3-month and 6-month)
- Patient Reported Outcome Measurement - Epworth Sleepiness Scale(Baseline and then 6-weekly up to 24 weeks)
- Patient Reported Outcome Measurement - Access, Availability and Convenience(Baseline and at 3-month and 6-month)
- Patient Reported Outcome Measurement - Hospital Anxiety and Depression Scale(Baseline and at 3-month and 6-month)
- Self-Reported Outcome Measurement - Caregiving Distress Scale(Baseline and at 3-month and 6-month)
- Patient Reported Outcome Measurement - Dyspnoea-12(Baseline and then 6-weekly up to 24 weeks)
- Patient Reported Outcome Measurement - General Satisfaction(Baseline and at 3-month and 6-month)
- Patient Reported Outcome Measurement - Neurological Fatigue Index for MND(Baseline and then 6-weekly up to 24 weeks)
- Patient Reported Outcome Measurement - the World Health Organization Quality of Life Scale-BREF(Baseline and at 3-month and 6-month)
- Patient Reported Outcome Measurement - 5-level EQ-5D(Baseline and at 3-month and 6-month)
- Service evaluation(At the end of study i.e. at 6-month)