Dichter 2021.

Study name	Evaluation of a multi‐component, non‐pharmacological intervention to prevent and reduce sleep disturbances in people with dementia living in nursing homes (MoNoPol‐sleep): study protocol for a cluster‐randomized exploratory trial
Methods	Cluster‐randomised exploratory trial
Participants	Inclusion criteria: cluster level: ≥ 50 residents to be included; sufficient resources (staff and time) to conduct the study and to implement the intervention; no parallel dementia‐specific care‐related project is being conducted there during the MoNoPol‐Sleep trial resident level: dementia diagnosis or a score of ≥ 3 on the Dementia Screening Scale; presence of ≥ 2 sleep problems according to the Sleep Disorder Inventory; length of stay ≥ 2 weeks in the respective cluster nurse level: a contract for at least part‐time (half‐a‐day) work; ≥ 3 night shifts during the last 3 months prior to data collection Exclusion criteria: documented sleep apnoea REM sleep‐behaviour disorders respite care
Interventions	Intervention: multicomponent intervention consists of 6 components: 1. assessment of established sleep‐promoting interventions and an appropriate environment in the participating nursing homes; 2. implementation of 2 'sleep nurses' as change agents per nursing home; 3. basic education course for nursing staff: "Sleep problems in dementia"; 4. an advanced education course for nursing staff: "Tailored problem‐solving" (2 workshops); 5. workshops: "Development of an institutional sleep‐promoting concept" (2 workshops with nursing management and sleep nurses); and 6. written information and education material (e.g. brochure and "One Minute Wonder" poster). Intervention will be performed over 16 weeks. Control: usual care
Outcomes	Primary outcome: prevalence of sleep problems Secondary outcomes: quality of life, quality of sleep, daytime sleepiness, agitated behaviour, psychotropic medication, falls, and physical restraints
Starting date	November 2020
Contact information	martin.dichter@uk‐koeln.de
Notes