- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Peter L. Kolominsky-Rabas, Univ.-Prof. Dr. med.
- Numero di telefono: +49 9131 85-35855
- Email: peter.kolominsky-rabas@fau.de
Luoghi di studio
-
-
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Aschaffenburg, Germania, 63739
- Reclutamento
- Klinikum Aschaffenburg-Alzenau
-
Contatto:
- Jan Dorr, Dr. med.
- Numero di telefono: +49 6021 32-3062
- Email: geriatrie@klinikum-ab-alz.de
-
Bad Aibling, Germania, 83043
- Reclutamento
- Schön Klinik Bad Aibling
-
Contatto:
- Klaus Jahn, Prof. Dr.
- Numero di telefono: +49 8061 903-0
- Email: kljahn@schoen-klinik.de
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Bad Neustadt an der Saale, Germania, 97616
- Reclutamento
- RHÖN-KLINIKUM Campus Bad Neustadt
-
Contatto:
- Renate Weinhardt
- Numero di telefono: +49 9771 66-24335
- Email: renate.weinhardt@campus-nes.de
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Bayreuth, Germania, 95445
- Reclutamento
- Klinikum Bayreuth
-
Contatto:
- Thomas Tümena
- Numero di telefono: +49 921 400-6680
- Email: thomas.tuemena@klinikum-bayreuth.de
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Coburg, Germania, 96450
- Reclutamento
- Klinikum Coburg, Regiomed Zentrum für Altersmedizin
-
Contatto:
- Johannes Kraft, Prof. Dr. med.
- Numero di telefono: +49 9561 22-7304
- Email: johannes.kraft@klinikum-coburg.de
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Freyung, Germania, 94078
- Reclutamento
- Kliniken Am Goldenen Steig
-
Contatto:
- Thomas Motzek-Noé, Dr. med.
- Numero di telefono: +49 8551 977-1160
- Email: KD@frg-kliniken.de
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München, Germania, 80335
- Reclutamento
- Marion von Tessin Memory-Zentrum
-
Contatto:
- Eva Demmel
- Numero di telefono: +49 89 21 54321-0
- Email: e.demmel@mvt-zentrum.de
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München, Germania, 80804
- Reclutamento
- Schön Klinik München Schwabing
-
Contatto:
- Jürgen Herzog, Dr.
- Numero di telefono: +49 89 36087-132
- Email: jherzog@schoen-klinik.de
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Neumarkt, Germania, 92318
- Reclutamento
- Klinikum Neumarkt
-
Contatto:
- Martin Ritt, Prof. Dr. med. habil. Dr. med.
- Numero di telefono: +49 9181 420-3076
- Email: martin.ritt@klinikum.neumarkt.de
-
Nuremberg, Germania, 90419
- Reclutamento
- Klinikum Nürnberg
-
Contatto:
- Lea Bräuer
- Numero di telefono: +49 911 398-3943
- Email: gedaechtnissprechstunde@klinikum-nuernberg.de
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Regensburg, Germania, 93053
- Reclutamento
- Klinik und Poliklinik für Psychiatrie Regensburg
-
Contatto:
- Stefan Werner, Dr. med.
- Numero di telefono: +49 941 941-1221
- Email: gedaechtnis-psy-r@medbo.de
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Rosenheim, Germania, 83022
- Reclutamento
- Böhm-Peters - Praxis für Psychiatrie, Psychotherapie und Neurologie
-
Contatto:
- Henning Peters, Dr. Dr. med.
- Numero di telefono: +49 8031 2213-000
- Email: sbp@kns-rosenheim.de
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
People with cognitive impairments
People with mild cognitive impairment and people with dementia
|
|
Family caregivers
Family caregivers of the people with cognitive impairments
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Genere
Lasso di tempo: Linea di base
|
Linea di base
|
|
|
Formazione scolastica
Lasso di tempo: Linea di base
|
Linea di base
|
|
|
Religion
Lasso di tempo: Baseline
|
Baseline
|
|
|
Età
Lasso di tempo: Basale
|
da anni
|
Basale
|
|
Postal code
Lasso di tempo: Baseline
|
Baseline
|
|
|
Country of birth
Lasso di tempo: Baseline
|
Baseline
|
|
|
Parents' country of birth
Lasso di tempo: Baseline
|
Baseline
|
|
|
Most often spoken language in the household
Lasso di tempo: Baseline
|
Baseline
|
|
|
Vocational training
Lasso di tempo: Baseline
|
Baseline
|
|
|
Employment status
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Baseline
|
data collected only at memory-clinics
|
Baseline
|
|
Measures that were used for diagnostic evaluation
Lasso di tempo: 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)
Lasso di tempo: Baseline
|
Higher values indicate better cognitive performance, data collected only at memory-clinics
|
Baseline
|
|
Mini Mental State Examination (MMSE)
Lasso di tempo: 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)
Lasso di tempo: Baseline
|
Total Score Range: 0-30, higher values indicate better cognitive performance
|
Baseline
|
|
Barthel-Index
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disturbi cerebrovascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Malattie vascolari
- Malattia cardiovascolare
- Disordini mentali
- Tauopatie
- Malattie Neurodegenerative
- Arteriosclerosi
- Malattie arteriose occlusive
- Leucoencefalopatie
- Arteriosclerosi intracranica
- Malattie arteriose intracraniche
- Malattia di Alzheimer
- Demenza
- Disturbi neurocognitivi
- Demenza, Vascolare
Altri numeri di identificazione dello studio
- 253_20 B
- G42d-G8300-2017/1606-1110 (Altro numero di sovvenzione/finanziamento: Bavarian State Ministry of Health, Care and Prevention)
- DRKS00038679 (Identificatore di registro: German Clinical Trials Register)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Malattia di Alzheimer
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ProgenaBiomeRitiratoMalattia di Alzheimer | Malattia di Alzheimer, esordio precoce | Malattia di Alzheimer, esordio tardivo | Malattia di Alzheimer 1 | Malattia di Alzheimer 2 | Malattia di Alzheimer 3 | Malattia di Alzheimer 4 | Malattia di Alzheimer 7 | Malattia di Alzheimer 17 | Malattia di Alzheimer 5 | Malattia di Alzheimer... e altre condizioniStati Uniti
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University of SaskatchewanCenter of Molecular Immunology, CubaNon ancora reclutamentoMalattia di Alzheimer lieve | Morbo di Alzheimer moderatoCanada
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Centre Hospitalier Universitaire de NiceCompletatoPaziente Predemenziale di Alzheimer | Paziente demenziale di Alzheimer | TestimoneFrancia
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Evan ThomasReclutamentoDemenza | Demenza di Alzheimer | Demenza di Alzheimer (AD) | Malattia di Alzheimer | AlzheimerStati Uniti
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Stanford UniversityNon ancora reclutamentoMCI con aumentato rischio di malattia di Alzheimer | Malattia di AlzheimerStati Uniti
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Massachusetts Institute of TechnologyReclutamentoMalattia di Alzheimer | Malattia di Alzheimer, esordio precoce | Malattia di Alzheimer, esordio tardivo | Il morbo di Alzheimer | Morbo di Alzheimer (sottotipi inclusi) | AlzheimerStati Uniti
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Vincent Tay Khwee SoonSingapore General Hospital; Changi General Hospital; National Neuroscience InstituteReclutamentoMorbo di Alzheimer (AD) | Malattia di Alzheimer | Il morbo di Alzheimer | Demenza di tipo Alzheimer | Demenza di tipo AlzheimerSingapore
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University College, LondonImperial College London; National Institute for Health Research, United Kingdom; UK Dementia Research Institute Ltd e altri collaboratoriReclutamentoMorbo di Alzheimer (AD) | Lieve compromissione cognitiva dovuta al morbo di Alzheimer | Alzheimer Disease DementiaRegno Unito
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AphiosNon ancora reclutamentoDemenza | Malattia di Alzheimer 1 | Malattia di Alzheimer 2 | Malattia di Alzheimer 3