Digital Dementia Registry Bavaria (digiDEM Bayern): a Multicentre, Prospective, Longitudinal Register Study Including People With Mild Cognitive Impairment and Dementia as Well as Their Family Caregivers

Официальное название

Digital Dementia Registry Bavaria (digiDEM Bayern)

Обзор

Around 57 million people worldwide live with dementia, with approximately 10 million new cases diagnosed each year. By the end of 2023, around 1.8 million people were living with dementia in Germany, the majority of whom were over 65 years of age (1.7 million). In Bavaria, around 257,000 people were living with dementia in 2023. Providing care and support for these people in the future is one of the biggest challenges not only for the healthcare system, but also for society as a whole. This is particularly true when it comes to caring for people with dementia in rural areas. The Digital Dementia Registry Bavaria (digiDEM Bayern) is a health outcomes research project that aims to improve understanding of the clinical complexity, long-term progression, and care situation of dementia. digiDEM Bayern is a multicenter longitudinal study conducted in all administrative districts of Bavaria. Participants from both urban and rural areas are included. Participants are people with mild cognitive impairment (MCI) and people with mild to moderate dementia (defined according to ICD-10: F06.7, F00-F03) who are cared for at home by their family caregivers, as well as the family caregivers themselves. Prior to study enrollment, participants with cognitive impairments are assessed for their suitability for the study using brief cognitive tests (Mini Mental State Examination, Montreal Cognitive Assessment). Participants are then interviewed at several points in time (baseline, after 6 months, after 12 months, annually) on the basis of standardized, face-to-face interviews. Participation is voluntary. As part of the informed consent process, participants will be informed about the project in advance and asked to consent to participate in the study. Participants are recruited in all administrative districts in Bavaria. Participants are recruited and surveyed through institutions that are active in counseling, care, diagnosis, treatment, and care for people with dementia, including counseling facilities, care groups, and residential communities, as well as outpatient (memory clinics, outpatient care services, general practitioners and specialists), inpatient (acute care hospitals, district clinics, geriatric rehabilitation facilities) and semi-inpatient (geriatric day clinics, day care facilities) institutions.

Первичные конечные точки

• Postal code [Срок оценки: Baseline]
• Age [Срок оценки: Baseline]
• Gender [Срок оценки: Baseline]
• Country of birth [Срок оценки: Baseline]
• Parents' country of birth [Срок оценки: Baseline]
• Most often spoken language in the household [Срок оценки: Baseline]
• Religion [Срок оценки: Baseline]
• Education [Срок оценки: Baseline]
• Vocational training [Срок оценки: Baseline]
• Employment status [Срок оценки: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months]

Критерии участия

Критерии включения

• People with an MMSE score of 24-30 points and an additional MoCA score of 0-23 points
• People with an MMSE score of 15-23 points
• Living in a home environment
• All types of MCI and dementia according to the ICD-10 classification (F06.7, F00-F03)
• Main residence in Bavaria
• All age groups

Критерии исключения

• People with an MMST score of 24-30 points and an additional MoCA score of 24-30 points
• People with an MMST score of 0-14 points
• Permanent residence in a nursing home
• Psychiatric diagnoses (among others depression, schizophrenia, addiction)
• Deafness and/or blindness
• Aphasia

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 12 центров

• Klinikum Aschaffenburg-Alzenau — Aschaffenburg
• Schön Klinik Bad Aibling — Bad Aibling
• RHÖN-KLINIKUM Campus Bad Neustadt — Bad Neustadt an der Saale
• Klinikum Bayreuth — Bayreuth
• Klinikum Coburg, Regiomed Zentrum für Altersmedizin — Coburg
• Kliniken Am Goldenen Steig — Freyung
• Marion von Tessin Memory-Zentrum — München
• Schön Klinik München Schwabing — München
• … и ещё 4 центра

Публикации

• Dietzel N, Kurten L, Karrer L, Reichold M, Kohler L, Nagel A, Chmelirsch C, Seebahn K, Hladik M, Meuer S, Kirchner A, Holm K, Selau M, Wendel M, Trinkwalter J, Prokosch HU, Graessel E, Kolominsky-Rabas PL. Digital Dementia Registry Bavaria-digiDEM Bayern: study protocol for a multicentre, prospective, longitudinal register study. BMJ Open. 2021 Feb 8;11(2):e043473. doi: 10.1136/bmjopen-2020-043473 PMID 33558357
• Reichold M, Dietzel N, Chmelirsch C, Kolominsky-Rabas PL, Graessel E, Prokosch HU. Designing and Implementing an IT Architecture for a Digital Multicenter Dementia Registry: digiDEM Bayern. Appl Clin Inform. 2021 May;12(3):551-563. doi: 10.1055/s-0041-1731286. Epub 2021 Jun 16. PMID 34134149

Идентификаторы

NCT: NCT07721701 · 253_20 B · G42d-G8300-2017/1606-1110 · DRKS00038679

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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