Using Remote Telemonitoring to Detect Early Decline in Lung Function & Streamline Clinics in Adults With Cystic Fibrosis

NCT02399241 | Completed

• 1 other identifier: STH18185
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Lung Health research study (Development of a predictive model) - To determine whether the I-neb breathing parameters (flow data) can act as a surrogate marker for lung function (Forced Expiratory Volume in 1 second FEV1) hence allow early detection of decline in lung function in cystic fibrosis patients.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in 1 second

  The study will develop a predictive model and conduct a parallel service improvement project. It therefore does not have a specific primary outcome measure. The predictive model will be attempting to identify if there is a correlation between the I-neb breathing parameters (i.e. inhalation time, rest time) and lung function (Forced Expiratory Volume in 1 second FEV1). The clinic streaming will attempt to identify if the preclinic data (lung function, weight, adherence) can predict the clinic needs of a patient.

  Baseline to 6 months

Study Arms (1)

Remote telemonitoring of clinical data

EXPERIMENTAL

Bluetooth enabled nebuliser device (I-neb) providing breathing parameters and adherence data.

Device: Bluetooth enabled nebuliser device (I-neb)

Interventions

Bluetooth enabled nebuliser device (I-neb) DEVICE

Remote telemonitoring of clinical data

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a confirmed diagnosis of cystic fibrosis via genetic testing
• Patients aged 16 and above
• Patients using inhaled mucolytics (to loosen secretions) or antibiotic treatments via the I-neb for all or part of their treatment
• Patients who have capacity to give informed consent

You may not qualify if:

• Patients with a lung transplant
• Patients on the active transplant list
• Patients who are pregnant (due to the variability of lung function during pregnancy)
• Patients in the palliative end stage of their life
• Patients using inhaled treatments with no objective adherence measure

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, 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

• Rachael Curley, MB ChB MRCP

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 26, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 22, 2017

Record last verified: 2017-06

Locations

GB (1)