Early Detection of Pulmonary Exacerbations in Non-cystic Fibrosis Bronchiectasis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The change from baseline in the bronchiectasis impact measure scores at 6 months compared to baseline
研究概览
简要总结
The goal of this observational study is to learn about the use of equipment to monitor health at home in participants who have non-cystic fibrosis bronchiectasis. The main question[s] it aims to answer are:
- How acceptable participants find using home monitoring equipment.
- To find out if the data collected from home monitoring can help to detect chest infections (exacerbations) before participants get symptoms they are aware of.
Participants will be provided with -
- a handheld spirometer to record FEV1 (lung function)
- a Fitbit, or other compatible activity monitor, to record activity and heart rate
- a saturation monitor that fits painlessly on the end of the finger to record oxygen levels
- weighing scales to record weight
- a mini freezer and pre-labelled sample containers to store a daily sputum sample. There is enough room in the freezers for samples to be brought to routine clinic visits. We will provide a cool bag and freezer packs for this. A courier collection of the samples can be arranged if necessary.
Participants will be encouraged to perform lung function, activity and oxygen levels at least 4 x per week.
Participants will be guided through how to set up and use each piece of equipment by the research team. The devices all connect to a smartphone app called Breathe RM (Remote Monitor,) which is free to download, via Bluetooth. Once set up using the home monitoring devices and adding notes to the app should take no more than 15 minutes per day.
Participants will be asked to record in the app -
- episodes of pulmonary exacerbation that require antibiotic treatment
- their coughing and wellness scores daily
详细描述
The aim of the study is to find out if data collected from home monitoring and artificial intelligence (AI) in patients with non-Cystic Fibrosis bronchiectasis can be used to detect pulmonary exacerbations (chest infections) before participants get symptoms of an infection. The infection can then be treated sooner and therefore potentially reduce long term lung damage. This study builds on previous work that has been done with patients who have a lung condition called cystic fibrosis and has shown favourable results. The AI technology relates to the predictive algorithm and not to any devices.
Potential participants will be approached during routine clinic visits (face to face or virtual) to offer more information regarding the study, provided with written and verbal information, given the opportunity to ask questions and given ample time to make a decision regarding whether or not they would like to take part.
Fifty patients from Royal Papworth Hospital who have a diagnosis of non-Cystic Fibrosis Bronchiectasis and who have a history of one or more pulmonary exacerbations in the previous year will be asked to perform home monitoring, record episodes of infection and provide a daily sputum sample for 6 months.
Participants will be provided with -
- a handheld spirometer to record Forced expiratory volume in 1 second (FEV1) (lung function)
- a Fitbit, or other compatible activity monitor, to record activity and heart rate
- a saturation monitor that fits painlessly on the end of the finger to record oxygen levels
- weighing scales to record weight
- a mini freezer and pre-labelled sample containers to store a daily sputum sample. There is enough room in the freezers for samples to be brought to routine clinic visits. We will provide a cool bag and freezer packs for this. A courier collection of the samples can be arranged if necessary.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Under the care of the Lung Defence Clinic at Royal Papworth Hospital
- •CT confirmed diagnosis of bronchiectasis
- •Age >/= 18 years
- •Had two or more clinician defined APEs in the year prior to enrolment
- •Typically expectorates sputum daily
- •Considered suitable for home monitoring in the opinion of the investigator
- •Able to provide written informed consent
排除标准
- •Patients unable to provide written informed consent
- •Known cystic fibrosis
- •Lung transplant recipients or on lung transplant waiting list
- •Use of long-term oxygen therapy (LTOT) or non-invasive ventilation to manage respiratory failure
- •Patients unwilling to consent to their link anonymised data from home monitoring being used for research
- •Patients unable to use a smartphone. Patients who would like to take part but do not have a smartphone can be provided with one.
- •Patients who do not have reliable Wi-Fi at home or are unable to access public Wi-Fi at least twice per week.
- •Considered unsuitable for home monitoring in the opinion of the investigator
结局指标
主要结局
The change from baseline in the bronchiectasis impact measure scores at 6 months compared to baseline
时间窗: baseline and month 6
The Bronchiectasis Impact Measure is a validated, patient reported outcome measure across 8 domains (cough, sputum, breathlessness, tiredness, activity, general health, control, exacerbations) and the impact they have on daily life. It is measured on a scale on 0 to 10 with 0 being no impact on daily life and 10 being greatly impacts daily life (lower score better). Minimum score 0 maximum score 10. Higher score mean worse outcome.
次要结局
- The acceptability of home monitoring in participants with non-cystic fibrosis bronchiectasis(3 months and 6 months)
- Impact of home monitoring on acute exacerbation frequency(In preceding 12 months and at 6 months)