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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

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posted on 05.02.2019 by Martin Wildman, Marlene Hutchings, Madelynne Arden, Alicia O'Cathain, Sarah Drabble, Stephen J Walters, Paul Tappenden, Daniel Beever, Pauline Whelan, Judy Bradley, Hannah Cantrill, Chin Maguire, Daniel Hind
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.


Funding

This project was funded by the Programme Grants for Applied Research programme (RP-PG-1212-20015) and will be published in full in the NIHR Journals Library. This research presents independent research commissioned by the NIHR. The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, MRC, CCF, NETSCC, the Health Technology Assessment programme or the Department of Health.

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