Analysis of Remote Monitoring / Virtual Clinic Data in Adult Patients With Cystic Fibrosis (CF)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 475
- 试验地点
- 2
- 主要终点
- Change from baseline in the 12 domain Cystic Fibrosis Questionnaire Revised (CFQR) Score at 24 months
研究概览
简要总结
The goal of this observational study is to learn about the impact of home monitoring in adults with cystic fibrosis. The main questions it aims to answer are:
- how people with CF find using home monitoring equipment
- to see if by using home monitoring data acute respiratory exacerbations (chest infections) can be detected earlier than standard care
Participants will be provided with a range of home monitoring equipment -
- hand held spirometer (lung function)
- weighing scales
- oximeter (blood oxygen levels)
- activity and heart rate monitor
to measure health at home several times a week. This information links to an app on a smartphone which the participant and clinicians can see.
详细描述
This is a multi-centre, observational, prospective cohort study. 610 adult patients with CF will be recruited from the following four CF centres within the United Kingdom
- Royal Papworth Hospital, Cambridge
- University Hospital Llandough, Penarth Wales
- Queen Elizabeth University Hospital, Glasgow, Scotland
- Western General Hospital, Edinburgh, Scotland.
The study is designed to run as a non-disruptive study with no impact on routine clinical practice. Each participant will be actively involved in home monitoring / virtual clinics. linked-anonymised data will be uploaded to a secure National Health Service The approved web-based site for analysis via Microsoft Azure which implements the transmission integrity and confidentiality control by ensuring that cryptography is implemented through a hybrid model.
Clinical metadata including physiology home monitor / virtual clinic data, sputum volume and colour recording will be analysed to establish whether there are predictive signals that could be used as an early alert to clinical deterioration.
Patient level costing will be compared across the cohort and with historical controls to estimate the cost saving or additional cost of home monitoring / virtual clinics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from baseline in the 12 domain Cystic Fibrosis Questionnaire Revised (CFQR) Score at 24 months
时间窗: 24 months
CFQR is a validated, self reported quality of life questionnaire. It has 12 domains such as physical and psychological health. It is a scaled score of 0 to 100. 0 being the worst and 100 the best.
次要结局
- Change from baseline in lung function at 12 months(12 months)