A Standardized Multi-centre Analysis of Remote Monitoring in Cystic Fibrosis Adult Patients to Reduce Pulmonary Exacerbations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Home monitoring possible in adult Cystic Fibrosis patients
研究概览
简要总结
The study aims to establish if it is possible for people with Cystic Fibrosis to monitor a number of parameters on a daily basis at home which might predict respiratory infections before they have symptoms and which might also predict treatment failures before this is obvious with conventional measures.
详细描述
Participants will collect the following clinical information daily: pulse rate and oxygen saturations, wellness and cough scores, spirometry measurements, physical activity, temperature, weight and sleep quantity and quality. The patients will also collect daily sputum samples.
Data will be collected via Bluetooth-enabled devices and transmitted via a Smart-phone to a secure National Health Service approved web-based site to be analyzed.
The information obtained will allow the investigators to develop a software program that will identify signals that can predict the onset of a chest infection before symptoms develop.
The investigators will also measure specific substances in sputum to identify changes before, during and after chest infections. The investigators hope this additional information will enable them to more accurately predict the onset of chest infections in cystic fibrosis.
The results of this study will determine if it is possible to develop a simple sputum test for patients to use at home in combination with other home-based assessments of well-being to provide an early warning system of a chest infection before patients feel unwell.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride.
- •Age ≥ 18 years of age.
- •A history of at least 1 acute pulmonary exacerbation in the past 12 months.
- •Able to provide written informed consent.
- •Willing and able to produce daily sputum samples.
- •Willing and able to provide daily telemetric measure of several physiological parameters.
排除标准
- •Patients unable to provide written informed consent
- •Patients unable to produce daily sputum samples
- •Less than 1 infective pulmonary exacerbation in 12 months
- •Lung transplant recipients
结局指标
主要结局
Home monitoring possible in adult Cystic Fibrosis patients
时间窗: 6 months
This will be measured by the number of patients recruited into the study and the patients compliance / adherence to the study protocol
次要结局
- Whether daily monitoring can provide early warning of a new chest infection(6 months)
- Development of a web-based machine learning tool(6 months)
研究者
Judy Ryan
Research & Database Manager
Papworth Hospital NHS Foundation Trust