Abstract
Introduction
Breathlessness 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.
Methods
Breathless 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.
Results
47 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.
Conclusion
A definitive trial of a complex breathlessness intervention in patients with IPF and non-IPF fibrotic ILD is feasible with preliminary data supporting intervention effectiveness.
Breathlessness 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.
Methods
Breathless 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.
Results
47 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.
Conclusion
A definitive trial of a complex breathlessness intervention in patients with IPF and non-IPF fibrotic ILD is feasible with preliminary data supporting intervention effectiveness.
| Original language | English |
|---|---|
| Journal | BMJ Open Respiratory Research |
| Publication status | Accepted/In press (AAM) - 5 Dec 2024 |