Alzheimer Disease, Dementia in Other Diseases Classified Elsewhere, Mild Cognitive Disorder, Unspecified Dementia, Vascular Dementia
Conditions
Keywords
MCI, Dementia, Registry, Digital, Alzheimers Disease
Brief summary
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.
Interventions
None listed
Sponsors
University of Erlangen-Nürnberg Medical School
Universitätsklinikum Erlangen
Medical Valley EMN e. V.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postal code | Baseline | — |
| Age | Baseline | in years |
| Gender | Baseline | — |
| Country of birth | Baseline | — |
| Parents' country of birth | Baseline | — |
| Most often spoken language in the household | Baseline | — |
| Religion | Baseline | — |
| Education | Baseline | — |
| Vocational training | Baseline | — |
| Employment status | 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 | — |
| Marital status | 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 | — |
| Number of children | 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 | in general and those, who live in the same household |
| Number of persons living in the household | 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 | — |
| Relationship between the person with cognitive impairment and the family caregiver | 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 | — |
| Living arrangements | 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 | Which kind of living arrangement (own home environment, assisted living, shared apartment, others) and who are the people, who live in this arrangement (family caregiver, spouse, children, siblings, others) |
| Powers of attorney and guardianship | 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 | Existence of a power of attorney for health care, a living will, and legal guardianship (Vorsorgevollmacht, Patientenverfügung, gesetzliche Betreuung) |
| Severe disability | 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 | Does a person with cognitive impairments have a severe disability? (according to German law) |
| Name of the health insurance company | 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 | — |
| Monthly net income | 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 | in Euro and in categories (e.g. 0-1000€) |
| Use of care leave | 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 | — |
| Time of onset of the first symptoms | 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 | as date |
| Dementia diagnosis | 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 | according to ICD-10 |
| Time of diagnosis | 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 | as date |
| Age at the time of diagnosis | 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 | — |
| Person, who initiated the diagnostic evaluation | 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 | — |
| Facility, where the diagnosis was made | 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 | — |
| Specialist who made the diagnosis | 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 | — |
| Charlson Comorbidity Index (CCI) | Baseline | Total Score Range: 0-32 (without dementia), higher values indicate a worse (greater) comorbid disease burden, data collected only at memory-clinics |
| Risk factors | Baseline | data collected only at memory-clinics |
| Measures that were used for diagnostic evaluation | Baseline | medical history, imaging, laboratory diagnostics, specific measures, data collected only at memory-clinics |
| Consortium to Establish a Registry for Alzheimer's Disease (CERAD) | Baseline | Higher values indicate better cognitive performance, data collected only at memory-clinics |
| Mini Mental State Examination (MMSE) | 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 | Total Score Range: 0-30, higher values indicate better cognitive performance |
| Montreal Cognitive Assessment (MoCA) | Baseline | Total Score Range: 0-30, higher values indicate better cognitive performance |
| Barthel-Index | 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 | Total Score Range: 0-100, higher values indicate better functional independence (less disability) |
| Neuropsychiatric Inventory (NPI) | 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 | 12 domains, each frequency (1-4) × severity (1-3), Total Score Range: 0-144, higher values indicate worse (more/severe) neuropsychiatric symptoms |
| Number of falls requiring treatment in the last six months | 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 | — |
| Tendency to wander | 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 | Is the person with cognitive impairment trying to run away from home? |
| Resource Utilization in Dementia (RUD) | 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 | — |
| Dementia Assessment of Service Needs (DEMAND) | 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 | — |
| EuroQoL 5D (EQ-5D) | 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 | Total Score Range: -0.661 to 1, higher values indicate a better health-related quality of life |
| Lubben Social Network Scale (LSNS) | 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 | Total Score Range: 0-60, higher values indicate a better social network/less social isolation |
| Sources of information on health topics | 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 | Internet, TV/ radio, books, courses and lectures, newspaper and magazines, family, friends and collegues, pharmacies, healthcare professional, others (measured on a Likert scale, from unimportant to very important) |
| Last time, the internet was used | 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 | in categories |
| Average internet usage over the past three months | 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 | — |
| Devices that were used to access the internet | 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 | — |
| Purposes for using the Internet | 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 | — |
| Reasons for non-use of the internet | 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 | — |
| Mobility | 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 | Possession of a driver's licence and active participation in traffic |
| Burden Scale for Family Caregivers (BSFC) | 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 | Total Score Range: 0-30, higher values indicate a worse (greater) caregiver burden |
| Benefits of Being a Caregiver Scale (BBCS) | 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 | Total Score Range: 0-50, higher values indicate a better (more) perceived benefits from caregiving |
| Short Form 12 Health Survey (SF-12) | 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 | Physical health and mental health summary scores, Total Score Range: 0-100, norm based scoring, higher values indicate a better physical/mental health status |
Countries
Germany
Contacts
CONTACTPeter L. Kolominsky-Rabas, Univ.-Prof. Dr. med.
Outcome results
None listed