Abstract

To reduce sleep problems in people living with dementia using a multi-component intervention. Cluster-randomized controlled study with two parallel groups and a follow-up of 16 weeks. Using external concealed randomization, 24 nursing homes (NH) were allocated either to the intervention group (IG, 12 clusters, 126 participants) or the control group (12 clusters, 116 participants). Participants were eligible if they had dementia or severe cognitive impairment, at least two sleep problems, and residence of at least two weeks in a NH. The 16-week intervention consists of six components: (1) assessment of sleep-promoting activities and environmental factors in NHs, (2) implementation of two "sleep nurses," (3) basic education, (4) advanced education for staff, (5) workshops to develop sleep-promoting concepts, and (6) written information and education materials. The control group (CG) received standard care. Primary outcome was ≥ two sleep problems after 16 weeks assessed with the Sleep Disorders Inventory (SDI). Twenty-two clusters (IG = 10, CG = 12) with 191 participants completed the study. At baseline, 90% of people living with dementia in the IG and 93% in the CG had at least two sleep problems. After 16 weeks, rates were 59.3% (IG) vs 83.8% (CG), respectively, a difference of -24.5% (95% CI, -46.3% - -2.7%; cluster-adjusted odds ratio 0.281; 95% CI 0.087-0.909). Secondary outcomes showed a significant difference only for SDI scores after eight and 16 weeks. The MoNoPol-Sleep intervention reduced sleep problems of people living with dementia in NH compared to standard care.

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