Comparison of Health Outcomes in a Remote Monitoring Programme Versus Usual Care in Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 139
- 试验地点
- 13
- 主要终点
- Spirometry availability at clinical review at first and last clinic appointments during the study observation period
研究概览
简要总结
Interstitial lung disease (ILD) is a collective term for a group of diseases where the lungs become scarred causing breathlessness.
This research project will assess if remote digital monitoring of frequent spirometry and pulse oximetry can provide an additional way to monitor ILD and provide information to support virtual consultations. Outcomes in the remote monitoring group will be compared with usual care alone over 12 months.
Patients taking part will be randomly allocated to remote digital monitoring or to usual care (with an equal chance of either). Remote monitoring will be performed using an app provided by patientMpower Ltd which patients will be able to download onto a smartphone or tablet. The study team will provide a spirometer and oximeter for patients to measure their lung function (spirometry) and oxygen saturations. These devices link to the app via Bluetooth to record all measurements. Patients will be asked to do these measurements three times a week. Clinical teams will be asked to review all measurements at least once a fortnight.
Health outcomes will be described and compared between the two groups.
详细描述
This study hopes to understand more about how remote digital monitoring of spirometry and pulse oximetry fits within the clinical care of patients with interstitial lung disease. This study will randomise patients to either remote monitoring or usual care and then collect information about the trajectory of their interstitial lung disease treatment and monitoring for the next 12 months to understand the impact of remote monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Diagnosis of fibrotic interstitial lung disease
- •Aged at least 18 years
- •Owns a smartphone or tablet device
- •Has a mobile telephone number, email address and access to the internet at home
- •In clinic lung function assessment within 6 months prior to study entry including spirometry and gas transfer measurement
- •Intention to have at least two outpatient clinical reviews (either in person or virtual) within the study observation period of 12 months
- •Willing to allow home monitoring of their health including spirometry and pulse oximetry data
- •Understands how to use mobile technology (eg. has downloaded and used other "apps" on their mobile device; uses email)
- •Demonstrates willingness to measure spirometry and pulse oximetry three times weekly for the duration of the observation period
- •Fluent in English language
- •Written or electronic informed consent
排除标准
- •Unable to fulfil all inclusion criteria
- •Cognitive impairment
- •History of difficulties performing spirometry at previous clinic testing
- •Contraindications to spirometry (for example previous pneumothorax, unstable cardiac status, known aortic or cerebral aneurysm)
- •Serious concomitant conditions which place the patient at high risk of respiratory distress making them unsuitable to be managed at home.
- •Current or recent (within the last 6 weeks before baseline) participation in another research project
结局指标
主要结局
Spirometry availability at clinical review at first and last clinic appointments during the study observation period
时间窗: 12 months
Number of patients who have spirometry recorded with the preceding 2 weeks for review at the first and last clinical reviews during the observation period
次要结局
- Number of in-clinic lung function appointments per patient(12 months)
- Number of patients starting new treatments for their interstitial lung disease(12 months)
- Number of hospital admissions per patient(12 months)
- Change in health-related quality of life (EQ-5D-5L) score(12 months)
- Change in Generalised Anxiety Disorder Assessment (GAD-7)(12 months)
- Number of patients recording measurements at least once/week on at least 66% study weeks(12 months)
- Number of unscheduled reviews per patient(12 months)
- Number of clinical reviews per patient(12 months)
- Adherence to study measurements(12 months)
- Proportion of clinical reviews which are virtual(12 months)
- Number of patients who have chest CT scans(12 months)
- Change in forced vital capacity (FVC)(12 months)
- Number of patients with >10% decline in FVC(12 months)
- Change in patient recorded dyspnoea (mMRC) score(12 months)
- Change in King's Brief Interstitial Lung Disease (K-BILD) score(12 months)
- Change in Patient Activation Measure (PAM-13)(12 months)