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NCT Number: NCT07721701

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

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.

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Key information

Conditions

Mild Cognitive Disorder Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dementia Dementia in Other Diseases Classified Elsewhere Dementia, Vascular Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies Unspecified Dementia Vascular Dementia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Aschaffenburg-Alzenau, Aschaffenburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postal code

    Time frame: Baseline

  2. Age

    Time frame: Baseline

    in years

  3. Gender

    Time frame: Baseline

  4. Country of birth

    Time frame: Baseline

  5. Parents' country of birth

    Time frame: Baseline

  6. Most often spoken language in the household

    Time frame: Baseline

  7. Religion

    Time frame: Baseline

  8. Education

    Time frame: Baseline

  9. Vocational training

    Time frame: Baseline

  10. Employment status

    Time frame: 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

  11. Marital status

    Time frame: 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. Number of children

    Time frame: 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

  13. Number of persons living in the household

    Time frame: 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

  14. Relationship between the person with cognitive impairment and the family caregiver

    Time frame: 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

  15. Living arrangements

    Time frame: 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)

  16. Powers of attorney and guardianship

    Time frame: 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)

  17. Severe disability

    Time frame: 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)

  18. Name of the health insurance company

    Time frame: 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

  19. Monthly net income

    Time frame: 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€)

  20. Use of care leave

    Time frame: 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

  21. Time of onset of the first symptoms

    Time frame: 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

  22. Dementia diagnosis

    Time frame: 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

  23. Time of diagnosis

    Time frame: 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

  24. Age at the time of diagnosis

    Time frame: 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

  25. Person, who initiated the diagnostic evaluation

    Time frame: 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

  26. Facility, where the diagnosis was made

    Time frame: 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

  27. Specialist who made the diagnosis

    Time frame: 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

  28. Charlson Comorbidity Index (CCI)

    Time frame: Baseline

    Total Score Range: 0-32 (without dementia), higher values indicate a worse (greater) comorbid disease burden, data collected only at memory-clinics

  29. Risk factors

    Time frame: Baseline

    data collected only at memory-clinics

  30. Measures that were used for diagnostic evaluation

    Time frame: Baseline

    medical history, imaging, laboratory diagnostics, specific measures, data collected only at memory-clinics

  31. Consortium to Establish a Registry for Alzheimer's Disease (CERAD)

    Time frame: Baseline

    Higher values indicate better cognitive performance, data collected only at memory-clinics

  32. Mini Mental State Examination (MMSE)

    Time frame: 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

  33. Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline

    Total Score Range: 0-30, higher values indicate better cognitive performance

  34. Barthel-Index

    Time frame: 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)

  35. Neuropsychiatric Inventory (NPI)

    Time frame: 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

  36. Number of falls requiring treatment in the last six months

    Time frame: 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

  37. Tendency to wander

    Time frame: 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?

  38. Resource Utilization in Dementia (RUD)

    Time frame: 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

  39. Dementia Assessment of Service Needs (DEMAND)

    Time frame: 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

  40. EuroQoL 5D (EQ-5D)

    Time frame: 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

  41. Lubben Social Network Scale (LSNS)

    Time frame: 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

  42. Sources of information on health topics

    Time frame: 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)

  43. Last time, the internet was used

    Time frame: 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

  44. Average internet usage over the past three months

    Time frame: 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

  45. Devices that were used to access the internet

    Time frame: 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

  46. Purposes for using the Internet

    Time frame: 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

  47. Reasons for non-use of the internet

    Time frame: 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

  48. Mobility

    Time frame: 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

  49. Burden Scale for Family Caregivers (BSFC)

    Time frame: 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

  50. Benefits of Being a Caregiver Scale (BBCS)

    Time frame: 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

  51. Short Form 12 Health Survey (SF-12)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Peter L. Kolominsky-Rabas, Univ.-Prof. Dr. med.

CONTACT

[email protected]

+49 9131 85-35855

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • Medical Valley EMN e. V.
  • Universitätsklinikum Erlangen

Registry information

Official study title

Digital Dementia Registry Bavaria (digiDEM Bayern)

Acronym: digiDEM Bayern

Important dates

Study start
2020
Primary completion
2031
Study completion
2031
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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