Development and evaluation of an intervention to support Adherence to treatment in adults with Cystic Fibrosis: A randomised controlled trial and parallel process evaluation protocol

Cystic Fibrosis (CF) is a genetic disease that affects around 10,000 individuals in the UK. Individuals with CF are prone to lung infections; inhaled medications are required to stay healthy, costing £30 million annually, yet average adherence has been estimated at 36%. Patients with < 50% adherence to inhaled therapies often require more unscheduled emergency care and hospital admissions than high adherers (e.g. patients collecting >80% of prescribed medication). This is both costly to the healthcare system and distressing for patients with CF and their families.

This protocol details the procedures of a two-armed, superiority, open-labelled randomised controlled trial with a parallel, mixed methods process evaluation. This study aims to examine the efficacy of a complex intervention designed to help patients with CF to adhere to therapy, compared to usual care, on clinical and participant related outcomes. In addition, this trial aims to identify the best way to deliver the complex intervention.