Clinical trial NCT02416375: Home Monitoring to Predict Exacerbation in Cystic Fibrosis
Official title: A Standardized Multi-centre Analysis of Remote Monitoring in Cystic Fibrosis Adult Patients to Reduce Pulmonary Exacerbations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Cystic Fibrosis Trust
name: King's College Hospital NHS Trust
name: Royal Brompton & Harefield
name: The Leeds Teaching Hospitals NHS Trust
name: University Hospital Southampton NHS Foundation Trust
name: Microsoft Research
name: Frimley Park Hospital NHS Trust
name: University Hospitals Bristol and Weston NHS Foundation Trust
First posted: 2015-04-15
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Cystic Fibrosis patients who produce sputum daily and have not had a previous organ transplant, with a history of at least one pulmoanry exacerbation within the past 12 months.

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride.
2. Age ≥ 18 years of age.
3. A history of at least 1 acute pulmonary exacerbation in the past 12 months.
4. Able to provide written informed consent.
5. Willing and able to produce daily sputum samples.
6. Willing and able to provide daily telemetric measure of several physiological parameters.

Exclusion Criteria:

1. Patients unable to provide written informed consent
2. Patients unable to produce daily sputum samples
3. Less than 1 infective pulmonary exacerbation in 12 months
4. Lung transplant recipients

Primary outcomes:
measure: Home monitoring possible in adult Cystic Fibrosis patients
timeFrame: 6 months
Secondary outcomes:
measure: Whether daily monitoring can provide early warning of a new chest infection
timeFrame: 6 months
measure: Development of a web-based machine learning tool
timeFrame: 6 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Trust
state: Cambridgeshire
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Trust
Study officials:
affiliation: Papworth Hospital NHS
name: Andres Floto, Prof
role: PRINCIPAL_INVESTIGATOR
References: