A feasibility, wait-list design randomised controlled trial of a complex breathlessness intervention in idiopathic pulmonary fibrosis (BREEZE-IPF)

Crooks, Michael and Wright, Caroline and Hart, Simon and Allgar, Victoria and English, Anne and Swan, Flavia and Dyson, Judith and Richardson, Gerry and Twiddy, Maureen and Cohen, Judith and Simpson, Andrew and Huang, Chao and Sykes, Dominic and Johnson, Miriam J. (2024) A feasibility, wait-list design randomised controlled trial of a complex breathlessness intervention in idiopathic pulmonary fibrosis (BREEZE-IPF). BMJ Open Respiratory Research. ISSN 2052-4439 (In Press)

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Abstract

IntroductionBreathlessness is common and impairs the quality of life of people with idiopathic pulmonary fibrosis (IPF) and non-IPF fibrotic interstitial lung diseases (ILD). We report the findings of a multi-centre, fast-track (wait-list), mixed-methods, randomised-controlled, feasibility study of a complex breathlessness intervention in breathless IPF and non-IPF fibrotic-ILD patients.MethodsBreathless IPF and non-IPF fibrotic-ILD patients were randomised to receive the intervention within 1-week (fast-track) or after 8-weeks (wait-list). The intervention comprised two face-to-face and one telephone appointment during a 3-week period covering: breathing control, handheld fan-use, pacing and breathlessness management techniques, and techniques to manage anxiety. Feasibility and clinical outcomes were assessed to inform progression to, and optimal design for, a definitive trial. A qualitative sub-study explored barriers and facilitators to trial and intervention delivery. Results47 patients (M:F 38:9, mean [SD] age 73.9 [7.2]) were randomised with a recruitment rate of 2.5 participants per month across 3 sites. The adjusted mean differences [95% CI] for key clinical outcomes at 4-weeks post-randomisation were: Chronic Respiratory Questionnaire breathlessness mastery domain (0.45 [-0.07, 0.97]); and numerical rating scales for ‘worst’ (-0.93 [-1.95, 0.10]), ‘best’ (-0.19 [-1.38, 1.00]), ‘distress caused by’ (-1.84 [-3.29, -0.39]) and ‘ability to cope with’ (0.71 [-0.57, 1.99]) breathlessness within the past 24-hours. The qualitative sub-study confirmed intervention acceptability and informed feasibility and acceptability of study outcome measures. ConclusionA definitive trial of a complex breathlessness intervention in patients with IPF and non-IPF fibrotic ILD is feasible with preliminary data supporting intervention effectiveness. IntroductionBreathlessness is common and impairs the quality of life of people with idiopathic pulmonary fibrosis (IPF) and non-IPF fibrotic interstitial lung diseases (ILD). We report the findings of a multi-centre, fast-track (wait-list), mixed-methods, randomised-controlled, feasibility study of a complex breathlessness intervention in breathless IPF and non-IPF fibrotic-ILD patients.MethodsBreathless IPF and non-IPF fibrotic-ILD patients were randomised to receive the intervention within 1-week (fast-track) or after 8-weeks (wait-list). The intervention comprised two face-to-face and one telephone appointment during a 3-week period covering: breathing control, handheld fan-use, pacing and breathlessness management techniques, and techniques to manage anxiety. Feasibility and clinical outcomes were assessed to inform progression to, and optimal design for, a definitive trial. A qualitative sub-study explored barriers and facilitators to trial and intervention delivery. Results47 patients (M:F 38:9, mean [SD] age 73.9 [7.2]) were randomised with a recruitment rate of 2.5 participants per month across 3 sites. The adjusted mean differences [95% CI] for key clinical outcomes at 4-weeks post-randomisation were: Chronic Respiratory Questionnaire breathlessness mastery domain (0.45 [-0.07, 0.97]); and numerical rating scales for ‘worst’ (-0.93 [-1.95, 0.10]), ‘best’ (-0.19 [-1.38, 1.00]), ‘distress caused by’ (-1.84 [-3.29, -0.39]) and ‘ability to cope with’ (0.71 [-0.57, 1.99]) breathlessness within the past 24-hours. The qualitative sub-study confirmed intervention acceptability and informed feasibility and acceptability of study outcome measures. ConclusionA definitive trial of a complex breathlessness intervention in patients with IPF and non-IPF fibrotic ILD is feasible with preliminary data supporting intervention effectiveness.

Item Type:	Article
Dates:	Date Event 5 December 2024 Accepted
Subjects:	CAH01 - medicine and dentistry > CAH01-01 - medicine and dentistry > CAH01-01-01 - medical sciences (non-specific)
Divisions:	Faculty of Health, Education and Life Sciences > College of Nursing and Midwifery
Depositing User:	Gemma Tonks
Date Deposited:	16 Dec 2024 13:57
Last Modified:	16 Dec 2024 13:57
URI:	https://www.open-access.bcu.ac.uk/id/eprint/16030

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