RIGHT CF Study
Research type
Research Study
Full title
Using remote telemonitoring to detect early decline in lung function & streamline clinics in adults with cystic fibrosis
IRAS ID
167890
Contact name
Rachael Curley
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 2 days
Research summary
Cystic fibrosis (CF) is a lifelong genetic condition, causing recurrent chest infections and premature death due to lung failure. People with CF (PwCF) are required to take daily treatments and attend frequent clinics. Appointment slots are typically set to an average length due to a lack of information about a patient's status and needs. Inhaled treatments are often administered via the “I-neb” an ‘intelligent’ nebuliser that records adherence and breathing measurements (treatment inhalation and rest time). When lung function declines, usually due to chest infections this affects breathing measurements. The gold standard to detect a decline is measured using a spirometer.
This study aims to see whether changes in “I-neb” breathing measurements can act as a surrogate marker of lung function decline. It also plans to use pre-clinic data to understand how to streamline clinics (i.e. “red stream” for unstable patients scheduled a longer appointment; “green stream” for stable patients scheduled a shorter appointment).
We plan to recruit 50 PwCF to remotely monitor their condition over 12 months using a portable spirometer, digital weighing scales, and a “Bluetooth” enabled “I-neb” (allowing data to be transferred). Participants will be asked to measure their lung function every three weeks and when there is a change in the breathing measurements. Associated symptom scores will be recorded and data correlated to build a predictive model.
One week prior to clinic, participants will be asked to measure their lung function and weight. They will be asked if there is anything they wish to focus on in clinic and a symptom score performed. Inhaled adherence will be continually recorded and displayed for participants and the clinical team on a website ‘CFHealthHub’. Clinics will occur as normal with data collected to understand how future appointment slots could be bespoke and tailored to an individual’s characteristics and needs.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
15/YH/0131
Date of REC Opinion
5 May 2015
REC opinion
Further Information Favourable Opinion