Home Monitoring to Predict Exacerbation in Cystic Fibrosis

NCT02416375 | Completed DMC

• 1 other identifier: PO1955
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 2

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Home monitoring possible in adult Cystic Fibrosis patients

  This will be measured by the number of patients recruited into the study and the patients compliance / adherence to the study protocol

  6 months

Secondary Outcomes (2)

• Whether daily monitoring can provide early warning of a new chest infection

  6 months

• Development of a web-based machine learning tool

  6 months

Study Arms (1)

Observation

Adult Cystic Fibrosis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• Cystic Fibrosis Trust: collaborator
• King's College Hospital NHS Trust: collaborator
• Royal Brompton & Harefield: collaborator
• The Leeds Teaching Hospitals NHS Trust: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator
• Microsoft Research: collaborator
• Frimley Park Hospital NHS Trust: collaborator
• University Hospitals Bristol and Weston NHS Foundation Trust: collaborator

Study Sites (2)

Papworth Hospital NHS Trust

Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

Location

Papworth Hospital NHS Trust

Cambridge, CB23 3RE, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Daily sputum samples

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Andres Floto, Prof

  Papworth Hospital NHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research & Database Manager

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: April 15, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

GB (2)