Abstract
OBJECTIVE: To explore the feasibility and effect of a nurse-led integrated care intervention on health-related quality of life (QoL) and unplanned 90-day rehospitalisation in patients hospitalised due to acute exacerbation of COPD (AECOPD). METHOD: A monocentric non-randomized parallel cluster design was applied. The primary endpoint was the difference between Chronic Respiratory Questionnaire (CRQ) Mastery Scores at hospital discharge and 13 weeks post-discharge. Secondary endpoints were differences between other CRQ scores, numbers of rehospitalisations and self-reported exacerbations. The study would end either 13 weeks after the full sample size was achieved or when study time ran out. RESULTS: The study was terminated before reaching the targeted sample size. Of 174 invitees, 69 (39.7%, 30 control, 39 intervention) consented to participate. Of those, 47 completed the study, 45 of whom had complete data sets for the primary endpoint. No differences in QoL scores, unplanned COPD-related rehospitalisations or unplanned all-cause rehospitalisations were detected. The mean number of self-reported moderate exacerbations was higher in the intervention group (p = 0.006). CONCLUSION: The pilot study had slow recruitment, high drop-out rates, and no significant effect on 3-month outcomes. Further research should focus on enhancing the current understanding of how to motivate and recruit patients in this setting. CLINICALTRIALS.GOV ID: NCT04011332.