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. 2020 Oct 15;20(1):405.
doi: 10.1186/s12877-020-01807-1.

The MAKS-s study: multicomponent non-pharmacological intervention for people with severe dementia in inpatient care - study protocol of a randomised controlled trial

Kristina Diehl  1 , André Kratzer  2 , Elmar Graessel  2
Affiliations

The MAKS-s study: multicomponent non-pharmacological intervention for people with severe dementia in inpatient care - study protocol of a randomised controlled trial

Kristina Diehl et al. BMC Geriatr. .

Abstract

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).

Keywords: Behavioural and psychological symptoms of dementia; Nursing home; Psychosocial intervention; Quality of life; RCT; Severe dementia.

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Conflict of interest statement

None.

Comment in

References

    1. Schäufele M, Köhler L, Hendlmeier I, Hoell A, Weyerer S. Prevalence of dementia and medical care in German nursing homes: a nationally representative survey. Psychiatr Prax. 2013;40(4):200–206. doi: 10.1055/s-0033-1343141. - DOI - PubMed
    1. Auer SR, Höfler M, Linsmayer E, Beránková A, Prieschl D, Ratajczak P, Šteffl M, Holmerová I. Cross-sectional study of prevalence of dementia, behavioural symptoms, mobility, pain and other health parameters in nursing homes in Austria and the Czech Republic: results from the DEMDATA project. BMC Geriatr. 2018;18(1):178. doi: 10.1186/s12877-018-0870-8. - DOI - PMC - PubMed
    1. Jørgensen LB, Thorleifsson BM, Selbæk G, Šaltytė Benth J, Helvik AS. Physical diagnoses in nursing home residents - is dementia or severity of dementia of importance? BMC Geriatr. 2018;18(1):254. doi: 10.1186/s12877-018-0943-8. - DOI - PMC - PubMed
    1. Becker S, Kaspar R, Lindenthal M. Zentrale theoretische Zugänge zur Lebensqualität bei Demenz. In: Kruse A, editor. Lebensqualität bei Demenz? Heidelberg: AKA-Verlag; 2010. p. 73–97.
    1. Ngo J, Holroyd-Leduc JM. Systematic review of recent dementia practice guidelines. Age Ageing. 2015;44(1):25–33. doi: 10.1093/ageing/afu143. - DOI - PubMed

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