Trials / Completed
CompletedNCT02416375
Home Monitoring to Predict Exacerbation in Cystic Fibrosis
A Standardized Multi-centre Analysis of Remote Monitoring in Cystic Fibrosis Adult Patients to Reduce Pulmonary Exacerbations
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 147 (actual)
- Sponsor
- Papworth Hospital NHS Foundation Trust · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2018-01-01
- Completion
- 2019-01-01
- First posted
- 2015-04-15
- Last updated
- 2021-03-16
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02416375. Inclusion in this directory is not an endorsement.