Table 1

Trial registration data set of the DemWG study

Data category	Information
Primary registry and trial identification number	ISRCTN89825211.
Date of registration in primary registry	16 July 2019
Secondary identifying numbers	–
Source(s) of monetary or material support	Innovation Committee at the Federal Joint Committee (‘Innovationsausschuss beim Gemeinsamen Bundesausschuss’), general project administration: DLR Project Management Agency (‘DLR Projektträger’).
Primary sponsor	Innovation Committee at the Federal Joint Committee (‘Innovationsausschuss beim Gemeinsamen Bundesausschuss’), general project administration: DLR Project Management Agency (‘DLR Projektträger’).
Secondary sponsor(s)	–
Contact for public queries	Professor Dr Karin Wolf-Ostermann (wolf-ostermann@uni-bremen.de); PD Dr Carolin Donath (carolin.donath@uk-erlangen.de).
Contact for scientific queries	Professor Dr Karin Wolf-Ostermann (wolf-ostermann@uni-bremen.de); PD Dr Carolin Donath (carolin.donath@uk-erlangen.de).
Public title	Risk reduction of hospital admissions for people with dementia in German shared-housing arrangements with outpatient care.
Scientific title	Risk reduction of hospital admissions for people with dementia in German shared-housing arrangements with outpatient care through a complex intervention: a cluster-randomised controlled trial.
Countries of recruitment	Germany.
Health condition(s) or problem(s) studied	MCI, mild or moderate dementia (degenerative type, not solely vascular).
Intervention(s)—for details see table 2	Intervention group: Education of nursing staff and other people working in shared-housing arrangements in detecting health risk situations and possible action strategies. Awareness raising and continuing medical education (CME) of general practitioners regarding the risks and negative consequences of hospital admissions for people with dementia. Multicomponent non-pharmacological group intervention MAKS-mk+ for people with mild or moderate dementia and MCI in shared-housing arrangements. Control group: care as usual offered in each shared-housing arrangement (‘treatment as usual’).
Key inclusion and exclusion criteria	Ages eligible for study: senior; sexes eligible for study: all.
	Inclusion criteria: (1) resident of shared-housing arrangements (with outpatient care); (2) MCI or mild-to-moderate dementia; (3) shared-housing arrangement is located in Bavaria, Bremen, Hamburg or Berlin. In order to reach the target number of participants, we opened up the recruitment regions for the shared-housing arrangements to the remaining federal states of Germany.
	Exclusion criteria: (1) severe hearing impairment; (2) severe visual impairment; (3) severe dementia; (4) cognitive decline due to diseases other than dementia (eg, schizophrenia or Korsakoff syndrome); (5) permanently immobile; (6) no verbal communication in German possible; (7) history of more than one stroke; (8) history of severe major depression.
Study type	Cluster-randomised controlled multicentre intervention study, complex intervention, waitlist control group. Longitudinal data acquisition. Additionally, focus groups and expert interviews are planned. Panel study: analysis of health insurance data to calculate costs of health service utilisation.
Date of first enrolment	1 January 2020.
Target sample size	1260.
Recruitment status	Ongoing.
Primary outcome(s)	Hospital admissions in the preceding 6 months are measured by nursing documentation of frequency, reasons and dates of hospital admissions.
Key secondary outcomes	Quality of life, measured with QUALIDEM. Behavioural and psychological symptoms of dementia and agitation, measured with the Neuropsychiatric Inventory and the Cohen-Mansfield Agitation Inventory. Falls, measured with a self-developed questionnaire Cognition, measured with the Mini-Mental State Examination.

MCI, mild cognitive impairment.