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A feasibility, randomised controlled trial of a complex breathlessness intervention in idiopathic pulmonary fibrosis (BREEZE-IPF): study protocol

Wright, C., Hart, S., Allgar, V., English, A., Swan, F., Dyson, J. ORCID: 0000-0002-0928-0438, Richardson, G., Twiddy, M., Cohen, J. F., Hussain, J., Johnson, M., Hargreaves, I. and Crooks, M. G. (2019). A feasibility, randomised controlled trial of a complex breathlessness intervention in idiopathic pulmonary fibrosis (BREEZE-IPF): study protocol. ERJ Open Research, 5(4), 00186-2019. doi: 10.1183/23120541.00186-2019

Abstract

Introduction Idiopathic pulmonary fibrosis (IPF) is a chronic and progressive lung disease that causes breathlessness and cough that worsen over time, limiting daily activities and negatively impacting quality of life. Although treatments are now available that slow the rate of lung function decline, trials of these treatments have failed to show improvement in symptoms or quality of life. There is an immediate unmet need for evidenced-based interventions that improve patients' symptom burden and make a difference to everyday living. This study aims to assess the feasibility of conducting a definitive randomised controlled trial of a holistic, complex breathlessness intervention in people with IPF.

Methods and analysis The trial is a two-centre, randomised controlled feasibility trial of a complex breathlessness intervention compared with usual care in patients with IPF. 50 participants will be recruited from secondary care IPF clinics and randomised 1:1 to either start the intervention within 1 week of randomisation (fast-track group) or to receive usual care for 8 weeks before receiving the intervention (wait-list group). Participants will remain in the study for a total of 16 weeks. Outcome measures will be feasibility outcomes, including recruitment, retention, acceptability and fidelity of the intervention. Clinical outcomes will be measured to inform outcome selection and sample size calculation for a definitive trial.

Ethics and dissemination Yorkshire and The Humber – Bradford Leeds Research Ethics Committee approved the study protocol (REC 18/YH/0147). Results of the main trial and all secondary end-points will be submitted for publication in a peer-reviewed journal.

Publication Type: Article
Additional Information: Copyright ©ERS 2019 http://creativecommons.org/licenses/by-nc/4.0/ This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0.
Subjects: R Medicine > RC Internal medicine
Departments: School of Health Sciences > Nursing
Date Deposited: 04 Feb 2020 17:15
URI: https://openaccess.city.ac.uk/id/eprint/23658
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