Digital Dementia Registry Bavaria—digiDEM Bayern: study protocol for a multicentre, prospective, longitudinal register study

Abstract

IntroductionDementia is one of the most relevant widespread diseases, with a prevalence of currently 50 million people with dementia worldwide. The care of people with dementia will be one of the major challenges for healthcare systems worldwide. Digitalisation offers new possibilities to improve both dementia healthcare and health outcomes research as a fundament for national healthcare planning. The ‘Digital Dementia Registry Bavaria—digiDEM Bayern’ aims to improve the understanding of the complexity and long-term progression of dementia and the current care situation in Bavaria. Moreover, by offering digital services, digiDEM will actively contribute to improving the care situation in Bavaria.Methods and analysisdigiDEM will recruit people with dementia and their family caregivers in all administrative regions of Bavaria. All participants will undergo dementia screening prior to study inclusion in order to identify people with mild cognitive impairment and mild-to-moderate dementia. Participants will be followed up over a period of three years. Sociodemographic data, type of dementia, symptoms, diagnosis, cognitive trajectories, activities of daily living, behavioural and psychological symptoms, falls, resource utilisation, caregiver burden, quality of life, needs of people with dementia and their caregivers, mobility, use of media and sources of information will be assessed. The project will implement a digital web-based platform for data collection. Data will be collected by means of standardised online or face-to-face interviews.Ethics and disseminationThe study obtained ethical approval from the Ethics Committee of the Medical Faculty of Friedrich-Alexander-University Erlangen-Nürnberg (FAU) (application number: 253_20 B). Findings will be used for evidence-based decision-making for health decision-makers in order to optimise dementia healthcare in the state of Bavaria. Specific analyses will be conducted for the participating research partners. Results of the study will be published in peer-reviewed journals.

Designing and Implementing an IT Architecture for a Digital Multicenter Dementia Registry: digiDEM Bayern

“…digiDEM will collect data on the dementia care situation in all seven administrative districts of Bavaria over a period of 3 years to understand the long-term course of dementia, the care situation in rural and urban areas, and the needs of PWD and their caregivers. 10 These data findings are essential for the future development and optimization of national and regional structures in dementia care.…”

“…15 To ensure that PWD from all over Bavaria, including rural areas, are included in the study, it is necessary to manage approximately 300 research partners (RPs) who are collecting data while conducting interviews. 10 RPs are facilities or persons involved in a dementia service like counseling centers, daycare facilities, or memory clinics. Due to the electronic data capture (EDC) from such a large group of RPs, working as "interview centers" for digiDEM distributed all over Bavaria, the participants and RPs' management means a great challenge.…”

“…To address the significant challenges in research, care, and policy, the Bavarian State Ministry of Health and Care in Germany has initiated the “Digital Dementia Registry Bavaria – digiDEM Bayern.” 10 One primary purpose of digiDEM is to establish a digital registry of data from people with mild cognitive impairment and mild-to-moderate dementia (PWD) and their family caregivers. digiDEM will collect data on the dementia care situation in all seven administrative districts of Bavaria over a period of 3 years to understand the long-term course of dementia, the care situation in rural and urban areas, and the needs of PWD and their caregivers.…”

Demenz und Digitalisierung

“…Das Projekt zielt darauf ab, die Lebensbedingungen von Menschen mit Demenz/MCI und ihren pflegenden Angehörigen in Bayern, insbesondere in den ländlichen Regionen, zu verbessern sowie die klinische Komplexität und den Langzeitverlauf demenzieller Erkrankungen zu erfassen. digiDEM Bayern fußt dabei auf zwei Säulen: dem Aufbau eines digitalen Registers zur Versorgungsforschung und der Bereitstellung von digitalen Angeboten für Menschen mit Demenz/MCI, ihren pflegenden Angehörigen, Demenzversorger*innen und die interessierte Allgemeinbevölkerung [19].…”

“…weiterführend mit dem Montreal Cognitive Assessment (MoCA)[24]. Zuvor wird eine schriftliche Einwilligungserklärung des potenziellen Studienteilnehmenden eingeholt[19]. Der MoCA weist im Vergleich zum MMST eine höhere Sensitivität bei leichten kognitiven Funktionseinschränkungen auf, weshalb Menschen mit MCI zuverlässiger identifiziert werden können[25].…”