To identify whether home monitoring of multiple physiological parameters and biomarkers in sputum could provide advanced warning of an infective exacerbation or treatment failure before changes in patient-reported symptoms.
1. To determine if longitudinal profiling of sputum from Cystic Fibrosis patients allow accurate prediction of exacerbations in a study of a larger group and can we confirm the 7+ day early warning system works in this larger group. 2. Is one biomarker sufficient to predict exacerbations - what is the accuracy? Are two or more biomarkers required to achieve an accuracy of greater than 95%? 3. Can we now accurately determine how many hospital bed days a home testing/wellness monitoring device would save? What is the business case for healthcare providers to adopt our future test for home use? We estimate a 50% saving. Can this be confirmed? 4. When used in the clinic, how many hospital days would our test save through faster determination of treatment efficacy? What is the business case for adopting our future test as a point of care test on the ward in Cystic Fibrosis centres? Could this be the new revolutionary tool that we anticipate? 5. We forecast a 50% reduction in costs to treat Cystic Fibrosis patients in disease severity bands 2-A to 5. Can we provide evidence for this to support further investment?
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
16
Record daily - peak flow measurements, pulse rate, oxygen saturation levels, weight,activity and daily sputum samples.
Papworth Hospital NHS Trust
Cambridge, United Kingdom
Advance warning of an infective exacerbation
To identify whether home monitoring of multiple physiological parameters and biomarkers in sputum could provide advanced warning of an infective exacerbation or treatment failure before changes in patient-reported symptoms. Participants will collect daily sputum samples which will be profiled for psuedomonas aeruginosa.
Time frame: one year
home monitoring of multiple physiological parameters
1. Daily peak flow measurements will be obtained for FEV1 and PEF 2. Daily pulse rate and oxygen saturations levels 3. Participants will weigh themselves daily on study specfic scales 4. Participants will wear a step counter during waking hours to measure their activity levels.
Time frame: one year
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