An observational study in Dementia, Dementia Alzheimers and Mild Cognitive Impairment, sponsored by German Center for Neurodegenerative Diseases (DZNE). Status unknown at 6 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-10.
Sponsored by German Center for Neurodegenerative Diseases (DZNE) · Observational
Dementia Care Management (DeCM) is an evidence-based model of care in Germany. It has proven its efficacy and cost-effectiveness. However it has not been implemented into routine care so far.
The aim of this trial is to implement Dementia Care Management into routine care in a selected region in Germany and evaluate the process of implementation as well as the effect of Dementia Care Management on participants.
Recruited in regular routine care n=60 people with cognitive impairment and/ or their cares will receive Dementia Care Management provided by specifically trained and qualified dementia care managers for 6 months.
Data will be assessed and analysed prior to the implementation, immediately after having received the intervention and at a later time point.
The effect of the intervention on person-oriented health care outcomes wil be analysed as well as factors associated with that.
2,231 studies on the registry are indexed under Dementia; 549 are open to participants now.
This study's enrollment of 93 is below the median of 250 across 500 observational studies indexed under Dementia.
Browse Dementia studies →German Center for Neurodegenerative Diseases (DZNE) is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
People identified in routine care that have a cognitive impairment or live as carerer in a household with a person with cognitive impairment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Households identified in routine care receiving a home-based Dementia Care Management.
Other: Dementia Care Management
Comprehensive assessment of health care needs of person with cognitive impairment and caregiver followed by algorithm-/ and person-based support in health care planning, implementing and monitoring
unmet needs
generic standardized assessment implemented as computer-assisted intervention management system (CMS) addresses caregiver burden, medical needs, home care needs, psychosocial needs (depression, sleep quality, pain, hearing, seeing, teeth problems, dementia related problems caused by person with dementia (PwD), medical aids). Adding the needs indicated provides a number of unmet needs.
Time frame: 6 months after baseline assessment
unmet needs
generic standardized assessment implemented as computer-assisted intervention management system (CMS) addresses caregiver burden, medical needs, home care needs, psychosocial needs (depression, sleep quality, pain, hearing, seeing, teeth problems, dementia related problems caused by PwD, medical aids). Adding the needs indicated provides a number of unmet needs.
Time frame: 12 months after baseline assessment
Antidementia drug treatment
A computer-based home medication review (HMR) encompasses all medications used by the study participants and includes questions about compliance, adverse effects and drug administration. The collection of primary data on medication in the context of the HMR includes both prescription drugs and over-the-counter drugs. The assignment was then integrated using a master file of the Pharmaceutical Index. The following antidementia drugs will be considered: donepezil (N06AD02), rivastigmine (N06AD03), galantamine (N06AD04) and memantine (N06AX01)
Time frame: 12 months after baseline assessment
Antidementia drug treatment
A computer-based home medication review (HMR) encompasses all medications used by the study participants and includes questions about compliance, adverse effects and drug administration. The collection of primary data on medication in the context of the HMR includes both prescription drugs and over-the-counter drugs. The assignment was then integrated using a master file of the Pharmaceutical Index. The following antidementia drugs will be considered: donepezil (N06AD02), rivastigmine (N06AD03), galantamine (N06AD04) and memantine (N06AX01)
Time frame: 6 months after baseline assessment
Neuropsychiatric Symptoms
Neuropsychiatric Inventory (NPI; Cummings 1997); The NPI represents an interview by proxy on twelve dimensions of neuropsychiatric behaviors, i.e. delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The presence (0= no, 1= yes) is asked. If present, the severity (rated 1 through 3; mild to severe) and frequency (1 to 4, rarely to very often) of each neuropsychiatric symptom are rated on. Thus the score for each dimension ranges from 0 = not present, 1= mildly and rarely to 12 = severe and often. A total NPI score is calculated as the sum of the frequency by severity scores ofeach domain range: 0 to 144, the higher the more neuropsychiatric symptomatic).
Time frame: 6 months after baseline assessment
Neuropsychiatric Symptoms
Neuropsychiatric Inventory (NPI; Cummings 1997); The NPI represents an interview by proxy on twelve dimensions of neuropsychiatric behaviors, i.e. delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The presence (0= no, 1= yes) is asked. If present, the severity (rated 1 through 3; mild to severe) and frequency (1 to 4, rarely to very often) of each neuropsychiatric symptom are rated on. Thus the score for each dimension ranges from 0 = not present, 1= mildly and rarely to 12 = severe and often. A total NPI score is calculated as the sum of the frequency by severity scores of each domain range: 0 to 144, the higher the more neuropsychiatric symptomatic).
Time frame: 12 months after baseline assessment
Caregiver Burden
The revised version of the Zarit-Burden Inventory (ZBI; Zarit et al., 1980) will be used.The revised version ZBI is a caregiver self-report measure to examine burden which is associated with functional/behavioural impairments and home care situation. It contains 22 items using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always).Total scores range from 0 indicating low burden to 88 indicating high burden.
Time frame: 6 months after baseline assessment
Caregiver Burden
The revised version of the Zarit-Burden Inventory (ZBI; Zarit et al., 1980) will be used.The revised version ZBI is a caregiver self-report measure to examine burden which is associated with functional/behavioural impairments and home care situation. It contains 22 items using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always).Total scores range from 0 indicating low burden to 88 indicating high burden.
Time frame: 12 months after baseline assessment
cognition
The Mini Mental State Examination (MMSE; Cockrell \& Folstein, 1988) will be used. The MMSE is a 30-point questionnaire to measure cognitive impairment. The questions are grouped into seven categories, each representing a different cognitive domain or function: Orientation to time (5 points); Orientation to place (5 points); Registration of three words (3 points); Attention and Calculation (5 points); Recall of three words (3 points); Language (8 points) and Visual Construction (1 point). Scores of 25-30 out of 30 are considered normal; 21-24 as mild, 10-20 as moderate and \<10 as severe impairment.
Time frame: 6 months after baseline assessment
cognition
The Mini Mental State Examination (MMSE; Cockrell \& Folstein, 1988) will be used. The MMSE is a 30-point questionnaire to measure cognitive impairment. The questions are grouped into seven categories, each representing a different cognitive domain or function: Orientation to time (5 points); Orientation to place (5 points); Registration of three words (3 points); Attention and Calculation (5 points); Recall of three words (3 points); Language (8 points) and Visual Construction (1 point). Scores of 25-30 out of 30 are considered normal; 21-24 as mild, 10-20 as moderate and \<10 as severe impairment.
Time frame: 12 months after baseline assessment
frailty
Frailty will be assessed using the Edmonton frailty scale (EFS; Rolfson et al. 2006) will be used. The EFS is reliable tool in geriatric medicine to assess the frailty of older patients on the domains Cognition, General health status, Functional independence, Social support, Medication use, Nutrition, Mood, Continence and Functional performance.
Time frame: 6 months after baseline assessment
frailty
Frailty will be assessed using the Edmonton frailty scale (EFS; Rolfson et al. 2006) will be used. The EFS is reliable tool in geriatric medicine to assess the frailty of older patients on the domains Cognition, General health status, Functional independence, Social support, Medication use, Nutrition, Mood, Continence and Functional performance.
Time frame: 12 months after baseline assessment
(health-related) quality of life
Quality of life will be assessed using the the health-related quality of life questionnaire (EQ-5D), a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
Time frame: 6 months after baseline assessment
(health-related) quality of life
Quality of life will be assessed using EQ-5D, a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.
Time frame: 12 months after baseline assessment
Plan to share: Yes — We will share data upon reasonable request and only aggregated data
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: data will become available after end of project - approx. 1/25
Access criteria: upon reasonable request to the responsible study investigator
This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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German Center for Neurodegenerative Diseases (DZNE)