Digital Dementia Registry Bavaria (digiDEM Bayern)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 12
- 主要终点
- Postal code
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Postal code
时间窗: Baseline
Age
时间窗: Baseline
in years
Gender
时间窗: Baseline
Country of birth
时间窗: Baseline
Parents' country of birth
时间窗: Baseline
Most often spoken language in the household
时间窗: Baseline
Religion
时间窗: Baseline
Education
时间窗: Baseline
Vocational training
时间窗: Baseline
Employment status
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
in general and those, who live in the same household
Number of persons living in the household
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Which kind of living arrangement (own home environment, assisted living, shared apartment, others) and who are the people, who live in this arrangement (family caregiver, spouse, children, siblings, others)
Powers of attorney and guardianship
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Existence of a power of attorney for health care, a living will, and legal guardianship (Vorsorgevollmacht, Patientenverfügung, gesetzliche Betreuung)
Severe disability
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Does a person with cognitive impairments have a severe disability? (according to German law)
Name of the health insurance company
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
in Euro and in categories (e.g. 0-1000€)
Use of care leave
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
as date
Dementia diagnosis
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
according to ICD-10
Time of diagnosis
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
as date
Age at the time of diagnosis
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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)
时间窗: Baseline
Total Score Range: 0-32 (without dementia), higher values indicate a worse (greater) comorbid disease burden, data collected only at memory-clinics
Risk factors
时间窗: Baseline
data collected only at memory-clinics
Measures that were used for diagnostic evaluation
时间窗: Baseline
medical history, imaging, laboratory diagnostics, specific measures, data collected only at memory-clinics
Consortium to Establish a Registry for Alzheimer's Disease (CERAD)
时间窗: Baseline
Higher values indicate better cognitive performance, data collected only at memory-clinics
Mini Mental State Examination (MMSE)
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Total Score Range: 0-30, higher values indicate better cognitive performance
Montreal Cognitive Assessment (MoCA)
时间窗: Baseline
Total Score Range: 0-30, higher values indicate better cognitive performance
Barthel-Index
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Total Score Range: 0-100, higher values indicate better functional independence (less disability)
Neuropsychiatric Inventory (NPI)
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
12 domains, each frequency (1-4) × severity (1-3), Total Score Range: 0-144, higher values indicate worse (more/severe) neuropsychiatric symptoms
Number of falls requiring treatment in the last six months
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Is the person with cognitive impairment trying to run away from home?
Resource Utilization in Dementia (RUD)
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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)
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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)
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Total Score Range: -0.661 to 1, higher values indicate a better health-related quality of life
Lubben Social Network Scale (LSNS)
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Total Score Range: 0-60, higher values indicate a better social network/less social isolation
Sources of information on health topics
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Internet, TV/ radio, books, courses and lectures, newspaper and magazines, family, friends and collegues, pharmacies, healthcare professional, others (measured on a Likert scale, from unimportant to very important)
Last time, the internet was used
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
in categories
Average internet usage over the past three months
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Possession of a driver's licence and active participation in traffic
Burden Scale for Family Caregivers (BSFC)
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Total Score Range: 0-30, higher values indicate a worse (greater) caregiver burden
Benefits of Being a Caregiver Scale (BBCS)
时间窗: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Total Score Range: 0-50, higher values indicate a better (more) perceived benefits from caregiving
Short Form 12 Health Survey (SF-12)
时间窗: Baseline, after 6 months, after 12 months, after 24 months, 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
次要结局
未报告次要终点