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

NCT07721701 | Recruiting DMC

• 3 other identifiers: 253_20 BG42d-G8300-2017/1606-1110DRKS00038679
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 12

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.

Conditions

Mild Cognitive Disorder; Alzheimer Disease; Vascular Dementia; Dementia in Other Diseases Classified Elsewhere; Unspecified Dementia

Keywords

MCI; Dementia; Registry; Digital; Alzheimers Disease

Outcome Measures

Primary Outcomes (51)

• Postal code

  Baseline

• Age

  in years

  Baseline

• 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

  in general and those, who live in the same 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

• 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

  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)

  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

• Powers of attorney and guardianship

  Existence of a power of attorney for health care, a living will, and legal guardianship (Vorsorgevollmacht, Patientenverfügung, gesetzliche Betreuung)

  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

• Severe disability

  Does a person with cognitive impairments have a severe disability? (according to German law)

  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

• 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

  in Euro and in categories (e.g. 0-1000€)

  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

• 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

  as date

  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 diagnosis

  according to ICD-10

  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 diagnosis

  as date

  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

• 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)

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

  Baseline

• Risk factors

  data collected only at memory-clinics

  Baseline

• Measures that were used for diagnostic evaluation

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

  Baseline

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

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

  Baseline

• Mini Mental State Examination (MMSE)

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

  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

• Montreal Cognitive Assessment (MoCA)

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

  Baseline

• Barthel-Index

  Total Score Range: 0-100, higher values indicate better functional independence (less 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

• Neuropsychiatric Inventory (NPI)

  12 domains, each frequency (1-4) × severity (1-3), Total Score Range: 0-144, higher values indicate worse (more/severe) neuropsychiatric 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

• 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

  Is the person with cognitive impairment trying to run away from home?

  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

• 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)

  Total Score Range: -0.661 to 1, higher values indicate a better health-related quality of life

  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

• Lubben Social Network Scale (LSNS)

  Total Score Range: 0-60, higher values indicate a better social network/less social isolation

  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

• Sources of information on health topics

  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)

  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

• Last time, the internet was used

  in categories

  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

• 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

  Possession of a driver's licence and active participation in traffic

  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

• Burden Scale for Family Caregivers (BSFC)

  Total Score Range: 0-30, higher values indicate a worse (greater) caregiver burden

  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

• Benefits of Being a Caregiver Scale (BBCS)

  Total Score Range: 0-50, higher values indicate a better (more) perceived benefits from caregiving

  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

• Short Form 12 Health Survey (SF-12)

  Physical health and mental health summary scores, Total Score Range: 0-100, norm based scoring, higher values indicate a better physical/mental health 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

Study Arms (2)

People with cognitive impairments

People with mild cognitive impairment and people with dementia

Family caregivers

Family caregivers of the people with cognitive impairments

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Universitätsklinikum Erlangen: collaborator
• Medical Valley EMN e. V.: collaborator

Study Sites (12)

Klinikum Aschaffenburg-Alzenau

Aschaffenburg, 63739, Germany

RECRUITING

Schön Klinik Bad Aibling

Bad Aibling, 83043, Germany

RECRUITING

RHÖN-KLINIKUM Campus Bad Neustadt

Bad Neustadt an der Saale, 97616, Germany

RECRUITING

Klinikum Bayreuth

Bayreuth, 95445, Germany

RECRUITING

Klinikum Coburg, Regiomed Zentrum für Altersmedizin

Coburg, 96450, Germany

RECRUITING

Kliniken Am Goldenen Steig

Freyung, 94078, Germany

RECRUITING

Marion von Tessin Memory-Zentrum

München, 80335, Germany

RECRUITING

Schön Klinik München Schwabing

München, 80804, Germany

RECRUITING

Klinikum Neumarkt

Neumarkt, 92318, Germany

RECRUITING

Klinikum Nürnberg

Nuremberg, 90419, Germany

RECRUITING

Klinik und Poliklinik für Psychiatrie Regensburg

Regensburg, 93053, Germany

RECRUITING

Böhm-Peters - Praxis für Psychiatrie, Psychotherapie und Neurologie

Rosenheim, 83022, Germany

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Official project website

MeSH Terms

Conditions

Neurocognitive Disorders; Alzheimer Disease; Dementia, Vascular; Dementia

Condition Hierarchy (Ancestors)

Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

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

CONTACT

+49 9131 85-35855; peter.kolominsky-rabas@fau.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 23, 2026
• Study Start: August 10, 2020
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: July 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

DE (12)