- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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 (digiDEM Bayern)
Digital Dementia Registry Bavaria (digiDEM Bayern)
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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Peter L. Kolominsky-Rabas, Univ.-Prof. Dr. med.
- Telefonní číslo: +49 9131 85-35855
- E-mail: peter.kolominsky-rabas@fau.de
Studijní místa
-
-
-
Aschaffenburg, Německo, 63739
- Nábor
- Klinikum Aschaffenburg-Alzenau
-
Kontakt:
- Jan Dorr, Dr. med.
- Telefonní číslo: +49 6021 32-3062
- E-mail: geriatrie@klinikum-ab-alz.de
-
Bad Aibling, Německo, 83043
- Nábor
- Schön Klinik Bad Aibling
-
Kontakt:
- Klaus Jahn, Prof. Dr.
- Telefonní číslo: +49 8061 903-0
- E-mail: kljahn@schoen-klinik.de
-
Bad Neustadt an der Saale, Německo, 97616
- Nábor
- RHÖN-KLINIKUM Campus Bad Neustadt
-
Kontakt:
- Renate Weinhardt
- Telefonní číslo: +49 9771 66-24335
- E-mail: renate.weinhardt@campus-nes.de
-
Bayreuth, Německo, 95445
- Nábor
- Klinikum Bayreuth
-
Kontakt:
- Thomas Tümena
- Telefonní číslo: +49 921 400-6680
- E-mail: thomas.tuemena@klinikum-bayreuth.de
-
Coburg, Německo, 96450
- Nábor
- Klinikum Coburg, Regiomed Zentrum für Altersmedizin
-
Kontakt:
- Johannes Kraft, Prof. Dr. med.
- Telefonní číslo: +49 9561 22-7304
- E-mail: johannes.kraft@klinikum-coburg.de
-
Freyung, Německo, 94078
- Nábor
- Kliniken Am Goldenen Steig
-
Kontakt:
- Thomas Motzek-Noé, Dr. med.
- Telefonní číslo: +49 8551 977-1160
- E-mail: KD@frg-kliniken.de
-
München, Německo, 80335
- Nábor
- Marion von Tessin Memory-Zentrum
-
Kontakt:
- Eva Demmel
- Telefonní číslo: +49 89 21 54321-0
- E-mail: e.demmel@mvt-zentrum.de
-
München, Německo, 80804
- Nábor
- Schön Klinik München Schwabing
-
Kontakt:
- Jürgen Herzog, Dr.
- Telefonní číslo: +49 89 36087-132
- E-mail: jherzog@schoen-klinik.de
-
Neumarkt, Německo, 92318
- Nábor
- Klinikum Neumarkt
-
Kontakt:
- Martin Ritt, Prof. Dr. med. habil. Dr. med.
- Telefonní číslo: +49 9181 420-3076
- E-mail: martin.ritt@klinikum.neumarkt.de
-
Nuremberg, Německo, 90419
- Nábor
- Klinikum Nürnberg
-
Kontakt:
- Lea Bräuer
- Telefonní číslo: +49 911 398-3943
- E-mail: gedaechtnissprechstunde@klinikum-nuernberg.de
-
Regensburg, Německo, 93053
- Nábor
- Klinik und Poliklinik für Psychiatrie Regensburg
-
Kontakt:
- Stefan Werner, Dr. med.
- Telefonní číslo: +49 941 941-1221
- E-mail: gedaechtnis-psy-r@medbo.de
-
Rosenheim, Německo, 83022
- Nábor
- Böhm-Peters - Praxis für Psychiatrie, Psychotherapie und Neurologie
-
Kontakt:
- Henning Peters, Dr. Dr. med.
- Telefonní číslo: +49 8031 2213-000
- E-mail: sbp@kns-rosenheim.de
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
People with cognitive impairments
People with mild cognitive impairment and people with dementia
|
|
Family caregivers
Family caregivers of the people with cognitive impairments
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Rod
Časové okno: Základní linie
|
Základní linie
|
|
|
Vzdělání
Časové okno: Základní linie
|
Základní linie
|
|
|
Religion
Časové okno: Baseline
|
Baseline
|
|
|
Stáří
Časové okno: Základní linie
|
v letech
|
Základní linie
|
|
Postal code
Časové okno: Baseline
|
Baseline
|
|
|
Country of birth
Časové okno: Baseline
|
Baseline
|
|
|
Parents' country of birth
Časové okno: Baseline
|
Baseline
|
|
|
Most often spoken language in the household
Časové okno: Baseline
|
Baseline
|
|
|
Vocational training
Časové okno: Baseline
|
Baseline
|
|
|
Employment status
Časové okno: 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
|
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
Časové okno: 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
|
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
Časové okno: 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
|
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
Časové okno: 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
|
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
Časové okno: 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
|
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
Časové okno: 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)
|
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
Časové okno: 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)
|
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
Časové okno: 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)
|
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
Časové okno: 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
|
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
Časové okno: 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€)
|
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
Časové okno: 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
|
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
Časové okno: 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
|
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
Časové okno: 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
|
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
Časové okno: 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
|
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
Časové okno: 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
|
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
Časové okno: 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
|
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
Časové okno: 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
|
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
Časové okno: 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
|
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)
Časové okno: Baseline
|
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
Časové okno: Baseline
|
data collected only at memory-clinics
|
Baseline
|
|
Measures that were used for diagnostic evaluation
Časové okno: Baseline
|
medical history, imaging, laboratory diagnostics, specific measures, data collected only at memory-clinics
|
Baseline
|
|
Consortium to Establish a Registry for Alzheimer's Disease (CERAD)
Časové okno: Baseline
|
Higher values indicate better cognitive performance, data collected only at memory-clinics
|
Baseline
|
|
Mini Mental State Examination (MMSE)
Časové okno: 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
|
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)
Časové okno: Baseline
|
Total Score Range: 0-30, higher values indicate better cognitive performance
|
Baseline
|
|
Barthel-Index
Časové okno: 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)
|
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)
Časové okno: 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
|
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
Časové okno: 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
|
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
Časové okno: 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?
|
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)
Časové okno: 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
|
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)
Časové okno: 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
|
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)
Časové okno: 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
|
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)
Časové okno: 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
|
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
Časové okno: 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)
|
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
Časové okno: 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
|
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
Časové okno: 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
|
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
Časové okno: 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
|
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
Časové okno: 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
|
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
Časové okno: 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
|
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
Časové okno: 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
|
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)
Časové okno: 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
|
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)
Časové okno: 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
|
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)
Časové okno: 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
|
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
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Cerebrovaskulární poruchy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Cévní onemocnění
- Kardiovaskulární choroby
- Duševní poruchy
- Tauopatie
- Neurodegenerativní onemocnění
- Arterioskleróza
- Arteriální okluzivní onemocnění
- Leukoencefalopatie
- Intrakraniální arterioskleróza
- Intrakraniální arteriální onemocnění
- Alzheimerova nemoc
- Demence
- Neurokognitivní poruchy
- Demence, Cévní
Další identifikační čísla studie
- 253_20 B
- G42d-G8300-2017/1606-1110 (Jiné číslo grantu/financování: Bavarian State Ministry of Health, Care and Prevention)
- DRKS00038679 (Identifikátor registru: German Clinical Trials Register)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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