Abstract

Introduction: Severe COPD impacts deeply on daily activities and is associated with high hospitalisation rate and poor prognosis. Objective: To investigate the effectiveness of a home-centered disease management program in reducing all-cause hospitalisations in severe COPD. Methods: GOLD III/IV COPD patients with at least 1 exacerbation in the previous year were randomised to disease (DM) or usual (UM) management. DM intervention included self-management coaching (“Living Well With COPD”) and decision support in case of clinical worsening over about 1 year. Results: 319 patients (74.3% on HOT, 27.3% on HMV) entered follow-up (Intention-To-Treat, ITT). Difference in yearly number of unscheduled all-cause hospital days (primary outcome) was -5,32 days [95%CI -13,69; 3,05](DM 17.4±35.4, UM 22.6±41.8, p=0.161 , Wilcoxon, ITT). It was -7.99 days [95%CI -16.62; 0.64], p=0.070 ) in Per Protocol (PP, eligibility criteria not fulfilled and/or having received p=0.074 ) in ITT and -8.26 ([95%CI -16.39; -0.12], p=0.047 ) in PP. No between-group differences were found in health status (SGRQ total score). More patients died in UM (n=23) than in DM (n=3, p ), mainly from respiratory cause (16 patients). Conclusions: This 1-yr intervention in severe COPD showed a non-statistically significant reduction of all-cause hospital days (those including nursing facility). Significant reductions in acute care hospital days (PP) and a lower number of deaths were shown with DM.

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