Background Nursing homes accommodate a large number of people with severe dementia. More than 80% of residents with dementia suffer from behavioural and psychological symptoms, that can have consequences on the perceived burden of the formal caregivers. Internationally, the number of studies on non-pharmacological interventions for people with severe dementia is very small. One way to reduce these symptoms is to meet the needs of people with severe dementia. The non-pharmacological group intervention MAKS-s, which we will investigate in this study, is intended to reduce the behavioural and psychological symptoms and to improve the quality of life of such people. Additionally, we will investigate the effects on the burden carried by formal caregivers. Methods With the present study, we will investigate the effectiveness of a multicomponent non-pharmacological intervention for people with severe dementia living in nursing homes (primary target group). A power analysis indicated that 144 dementia participants should initially be included. In addition, a secondary target group (nursing home staff) will be examined with respect to their dementia-related stress experiences. The study will be conducted as a cluster randomised controlled trail in Germany with a 6-month intervention phase. The nursing homes in the waitlist control group will provide “care as usual.” The primary endpoints of the study will be the behavioural and psychological symptoms of dementia and the quality of life of people with severe dementia. The total duration of the study will be 18 months. Data will be collected by using observer rating scales. Discussion The project has some outstanding quality features. The external validity is high, because it is situated in a naturalistic setting in nursing homes and is being carried out with available nursing employees. Due to this fact, a permanent implementation also seems to be possible. Since the participating nursing homes are disseminated across several German federal states and rural and urban regions, the results should be transferable to the entire population. Trial registration ISRCTN15722923 (Registration date: 07 August 2019).

Background Severe dementia is one of the most challenging conditions when caring for people in nursing homes. A manualised non-pharmacological, psychosocial group intervention especially adapted to the needs of people with severe dementia (PWSDs) is currently still lacking. To close this gap, we adapted the evidence-based multicomponent non-pharmacological MAKS intervention (Motor stimulation, ADL stimulation, Cognitive [german: Kognitive] stimulation, and Social functioning in a group setting) to the special needs of PWSDs called the MAKS-s intervention, where the s stands for severe dementia. Methods In a prospective, multicentre, cluster-randomised trial with a waitlist control group design, 26 nursing homes comprising 152 PWSDs were randomly assigned to either the MAKS-s intervention group (IG) or control group (CG) – 121 PWSDs were still alive after the 6-month intervention period (t6) and included in the intention-to-treat (ITT) sample. The two primary outcomes, behavioural and psychological symptoms (BPSDs, measured with NPI-NH) and quality of life (QoL, measured with QUALIDEM), and the secondary outcome, activities of daily living (ADLs, measured with ADCS-ADL-sev), were assessed at baseline (t0) and at t6. Mixed ANOVAs were computed to investigate possible effects of the MAKS-s intervention on the outcomes. Results In the ITT sample, BPSDs and QoL did not change significantly over time, and group assignment did not affect them, although the IG participants had significantly better overall QoL than the CG participants. ADLs decreased significantly over time, but group assignment did not affect them. Analyses in the per protocol (PP) sample showed comparable results, with the exception that the IG participants showed a significantly greater increase in BPSDs than the CG participants did. Discussion Under the situational conditions of the Covid-19 pandemic, no beneficial effects of the MAKS-s intervention on BPSDs, QoL, or ADLs were observed. This finding also means that under ‘normal circumstances’ (i.e., if there had been no pandemic), we could not make any statements about the effect or non-effect of MAKS-s. In order to be able to address the hypotheses formulated here, the study will have to be repeated incorporating helpful experiences of the present study. Trial registration https://doi.org/10.1186/ISRCTN15722923 (Registered prospectively, 07. August 2019).

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