Analysis of Remote Monitoring/Virtual Clinic Data in Adult Patients With Cystic Fibrosis (Project Breathe)

NCT06222905 | Active Not Recruiting

• 1 other identifier: P02445
• Study Type: observational
• Target: 475
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to learn about the impact of home monitoring in adults with cystic fibrosis. The main questions it aims to answer are:

• how people with CF find using home monitoring equipment
• to see if by using home monitoring data acute respiratory exacerbations (chest infections) can be detected earlier than standard care Participants will be provided with a range of home monitoring equipment -
• hand held spirometer (lung function)
• weighing scales
• oximeter (blood oxygen levels)
• activity and heart rate monitor to measure health at home several times a week. This information links to an app on a smartphone which the participant and clinicians can see.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the 12 domain Cystic Fibrosis Questionnaire Revised (CFQR) Score at 24 months

  CFQR is a validated, self reported quality of life questionnaire. It has 12 domains such as physical and psychological health. It is a scaled score of 0 to 100. 0 being the worst and 100 the best.

  24 months

Secondary Outcomes (1)

• Change from baseline in lung function at 12 months

  12 months

Interventions

non interventional OTHER

non interventional

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with cystic fibrosis attending specialist cystic fibrosis centres

You may qualify if:

• Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride levels
• Age ≥ 18 years of age
• Able to provide written informed consent
• Patients who are known to be suitable for home monitoring and able to manage the process, those currently undertaking home monitoring / virtual clinics

You may not qualify if:

• Patients unable to provide written informed consent
• Patients unwilling to consent to their link anonymized data from home monitoring / virtual clinics being used for research
• Lung transplant recipients

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• Innovate UK: collaborator
• Cystic Fibrosis Trust: collaborator
• US Cystic Fibrosis Foundation: collaborator

Study Sites (2)

Royal Papworth Hospital

Cambridge, Cambridgeshire, CB2 0AA, United Kingdom

Location

Royal Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0BB, United Kingdom

Location

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

  Royal Papworth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: February 20, 2019
• Primary Completion: January 25, 2024
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

GB (2)