The RIGHT-CF Study
Cystic fibrosis (CF) is a lifelong genetic condition. It causes the body’s secretions to become thick and sticky resulting in the congestion of multiple organs. This can lead to breathing problems, recurrent chest infections, malabsorption, diabetes, and liver disease. To stay well people with CF (PwCF) are required to take daily treatments and attend frequent specialist clinics for review. Clinic slots are typically set to an average length due to a lack of information about a patient's status and needs. This can therefore lead to variation and queues.
The I-neb is an ‘intelligent’ nebuliser used to administer inhaled antibiotics and mucolytics to loosen secretions. It routinely records objective adherence and breathing parameters (inhalation and rest time). This means it can be used as a telemedicine device to remotely monitor PwCF and allow them to self-manage.
When lung function declines usually due to chest infections this affects the breathing parameters. The gold standard to detect a decline is currently the forced expiratory volume in the first one second (FEV1) measured with a spirometer. We plan to see whether changes in I-neb breathing parameter data can act as a surrogate marker of deterioration in lung function triggering an assessment. The hope is that this would allow early detection of a decline in lung function and prompt further management.
Remote monitoring of lung function, weight, and inhaled adherence also have the potential to be used to restructure clinics. We plan to recruit 50 people to remotely monitor these parameters in between clinic visits using a portable spirometer, digital weighing scales and a "Bluetooth" enabled I-neb. By using this preclinic data clinics can be bespoke, tailored to individual characteristics and needs. This has the advantage of reducing variation and queues for PwCF and allowing more efficient use of the multidisciplinary team resources.
Further details can be found at this clinical trial link.