Strengths and limitations
The main strength of our study was the randomised design with a rigorous method, with outcome assessors blinded to the group allocation for the primary outcome. None of the home care services dropped out during the study.Our main limitation is that with 380 included patients, only about 40% of the planned sample size of 960 was achieved. Although we were able to recruit 85% of the planned 32 home care services, the number of participating patients was much lower than expected and ranged between 5 and 28 per cluster (with a mean of 14.1 per cluster instead of the planned 30). Furthermore, the number of patients lost to follow-up was comparably high and attrition in the control group was somewhat higher. As we used last observation carried forward imputation for the primary outcome, about 40% of patients’ outcomes at 12 months were imputed with baseline values potentially leading to conservative estimates. However, in the pre-planned sensitivity analyses (complete case analysis and mixed model to investigate the development between t1 and t2), results were comparable. Furthermore, the intra-cluster correlation coefficient was higher than expected, also limiting statistical power of our study. Additionally, generalisability might also be limited as, compared to the general population,