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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
  1. André Kratzer1,
  2. Jennifer Scheel1,
  3. Karin Wolf-Ostermann2,
  4. Annika Schmidt2,
  5. Katrin Ratz2,
  6. Carolin Donath1,
  7. Elmar Graessel1
  1. 1Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany
  2. 2Department of Health Care Research, Institute of Public Health and Nursing Research (IPP), University of Bremen, Bremen, Germany
  1. Correspondence to André Kratzer; andre.kratzer{at}uk-erlangen.de

Abstract

Introduction Shared-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 analysis Based 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 dissemination All 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 number ISRCTN89825211.

  • dementia
  • delirium & cognitive disorders
  • geriatric medicine
http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors AK drafted the manuscript. AK, JS, KW-O, AS, KR, CD and EG are responsible for the conception and design of the study. JS, KW-O, AS, KR, CD and EG made substantial contributions to the manuscript and substantively and critically revised it. AK, JS, CD and EG developed the non-pharmacological group intervention MAKS-mk+ and the continuing medical education (CME) of general practitioners. KW-O, AS and KR developed the education of the nursing staff and other people working in shared-housing arrangements. All authors have read and approved the final version of the manuscript. All authors have agreed to be personally accountable for all aspects of the work and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated and resolved.

  • Funding The DemWG study is supported by grants from the German Innovation Committee at the Federal Joint Committee (‘Innovationsausschuss beim Gemeinsamen Bundesausschuss’, Gutenbergstraße 13, 10587 Berlin) with General Project Administration by the DLR Project Management Agency (‘DLR Projektträger’; Address: Heinrich-Konen-Straße 1, 53227 Bonn; Phone:+49 228 3821–1020, email: innovationsfonds-versorgungsforschung@dlr.de), grant number: 01VSF18054. The study protocol has been reviewed by the funding body.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the 'Methods and analysis' section for further details.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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