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Eur Respir J. 2019 Aug 14. pii: 1802134. doi: 10.1183/13993003.02134-2018. [Epub ahead of print]

Exacerbation action plans for patients with COPD and comorbidities: a randomised controlled trial.

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Department of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, the Netherlands
Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands.
College of Medicine and Public Health, Flinders University, Adelaide, Australia.
Department of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, the Netherlands.
Department of Research Methodology, Measurement, and Data-Analysis, Faculty of Behavioural, Management and Social sciences, University of Twente, Enschede, the Netherlands.
Department of Respiratory Medicine, Southern Adelaide Local Health Network, Adelaide, Australia.
Department of Pulmonary Medicine, Canisius-Wilhelmina Ziekenhuis, Nijmegen, the Netherlands.
Department of Statistics, Data Science and Epidemiology, Swinburne University of Technology, Melbourne, Australia.
Southern Adelaide Diabetes and Endocrine Services, Flinders Medical Centre, Adelaide, Australia.
Department of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, Australia.


This international randomised controlled trial evaluated whether COPD patients with comorbidities, trained in using patient-tailored multi-disease exacerbation action plans, had fewer COPD exacerbation days than usual care (UC).COPD patients (GOLD II-IV) with ≥1 comorbidity (ischaemic heart disease, heart failure, diabetes, anxiety, depression) were randomised to a patient-tailored self-management intervention (n=102) or UC (n=99). Daily symptom diaries were completed for 12 months. The primary outcome "COPD exacerbation days/patient/year" was assessed using intention-to-treat analyses.No significant difference was observed in the number of COPD exacerbation days/patient/year (self-management: median 9.6 (IQR 0.7-31.1); UC: median 15.6 (IQR 3.0-40.3); Incidence Rate Ratio (IRR) 0.87 (95% CI 0.54; 1.39); p=0.546). There was a significantly shorter duration per COPD exacerbation for self-management (self-management: median 8.1 (IQR 4.8-10.1) days; UC: median 9.5 (IQR 7.0-15.1) days; p=0.021), with no between-group differences in the total number of respiratory hospitalisations (IRR 0.76 (95% CI 0.42;1.35); p=0.348), but a lower probability of ≥1 respiratory-related hospitalisation compared to UC (Relative Risk (RR) 0.55 (95% CI 0.35; 0.87); p=0.008). No between-group differences were observed in all-cause hospitalisations (IRR 1.07 (95% CI 0.66; 1.72)) or mortality (self-management: n=4 (3.9%); UC: n=7 (7.1%); RR 0.55 (95% CI 0.17; 1.84)).Patient-tailored exacerbation action plans for COPD patients with comorbidities did not significantly reduce exacerbation days, but reduced the duration per COPD exacerbation and the risk of having at least one respiratory-related hospitalisation during follow-up, without excess all-cause mortality.

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