Disease Areas:
Cystic fibrosisDevice Types:
This paper describes the design of a prospective, single-center, non-blinded, randomized controlled mixed-methods trial designed to examine the effect of home monitoring on inpatient bed days in 100 adults registered at a cystic fibrosis center in Birmingham, United Kingdom. The primary endpoints are the number of hospital inpatient bed days and health-related QoL; secondary endpoints are antibiotic use, pulmonary exacerbations, lung function, body weight, BMI, anxiety and depression, and health economic outcomes. Measures of disease impairment include FEV1 and FVC, evaluated in an outpatient setting using a digital Vitalograph spirometer.
