The DemWG study: reducing the risk of hospitalisation through a complex intervention for people with dementia and mild cognitive impairment (MCI) in German shared-housing arrangements: study protocol of a prospective, mixed-methods, multicentre, cluster-randomised controlled trial

Abstract

IntroductionShared-housing arrangements (SHAs) are small, home-like care environments in Germany. Residents are predominantly people with dementia. The risk for all-cause hospitalisation is consistently higher for people with dementia compared with people without dementia and there is currently no evidence-based intervention to reduce the risk of hospitalisation. Thus, the DemWG study investigates whether a complex intervention is effective in reducing hospitalisation (primary outcome), behavioural and psychological symptoms of dementia and falls and for stabilising cognitive functioning and quality of life in people with dementia and mild cognitive impairment (MCI) in German SHAs.Methods and analysisBased on the UK Medical Research Council framework ‘Developing and evaluating complex interventions’, a prospective, mixed-methods, multicentre, cluster-randomised controlled trial combining primary and secondary data analyses as well as quantitative and qualitative research methods is being conducted. The intervention consists of three parts: (A) education of nursing staff in SHAs; (B) awareness raising and continuing medical education (CME) of general practitioners; (C) multicomponent non-pharmacological group intervention MAKS-mk+ (‘m’=motor training; ‘k’=cognitive training; ‘+’=fall prevention) for people with dementia and MCI. Randomisation is stratified by the German federal states and type of setting (rural vs urban). Neither the trained professionals nor the participants are blinded. Data are collected at baseline and after 6, 12 and 18 months with standardised instruments. Quantitative data will be analysed by multivariate analyses according to the general linear model, qualitative data using qualitative content analysis. Recruitment is still ongoing until 31 December 2020.Ethics and disseminationAll procedures were approved by the Ethics Committee of the University of Bremen (Ref. 2019-18-06-3). Informed consent will be obtained before enrolment of participants. Due to findings of previous randomised controlled trials, serious adverse events are not expected. Results will be disseminated in peer-reviewed journal publications and conference presentations.Trial registration numberISRCTN89825211.

Agitation and aggression in people living with dementia and mild cognitive impairment in shared-housing arrangements – validation of a German version of the Cohen-Mansfield Agitation Inventory-Short Form (CMAI-SF)

“…The data were obtained from the baseline data of the cluster-randomized controlled trial “The DemWG study” [ 32 ] to evaluate a non-pharmacological complex intervention for people with dementia and mild cognitive impairment (MCI) in German SHAs (trial registration number: ISRCTN89825211). The sample consisted of N = 341 people with dementia or mild cognitive impairment living in 97 SHAs located in nine different German federal states [ 32 ]. Residents of the SHAs were included if they had mild-to-moderate dementia according to screening instruments (i.e.…”

Detecting agitation and aggression in persons living with dementia: a systematic review of diagnostic accuracy

“…Furthermore, four studies did not report their location [16,37,42,50]. The studies were published between 1989 and 2023 [42,58]. Dementia severity was determined mainly with the MMSE, or variations thereof, (n = 25) [22, 25, 31-34, 36-41, 43-48, 50-56, 58] with other studies using the Functional Assessment Staging Scale (FAST) (n = 2) [16,35], and Global Deterioration Scale (GDS) (n = 1) [49].…”

Krankenhauseinweisungsgründe für Menschen mit Demenz – ein Scoping-Review

“…Dies unterstreicht den Bedarf an spezifischen Interventionen, die an vermeidbaren Krankenhauseinweisungen für MmD und MmMCI ansetzen. Im Rahmen einer randomisierten kontrollierten Studie wird derzeit die Wirksamkeit einer solchen spezifischen Intervention untersucht [ 12 ].…”

“…Es wird davon ausgegangen, dass etwa jeder 4. Krankenhausaufenthalt von MmD und MmMCI vermeidbar ist [ 12 , 28 ]. Diese Gegebenheit unterstreicht die Relevanz, die Gründe hierfür zu untersuchen und zu kennen [ 28 ].…”