Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ZMI1-2521FSB907 | Other Grant/Funding Number | Federal Ministery of Health (BMG) | |
| BB110/22 | Other Identifier | Ethics Comittee of the Universitymedicine Greifswald |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Siegen | UNKNOWN |
| Gesundheitsregion Siegerland eG (GRS) | UNKNOWN |
| Alzheimer Gesellschaft Siegen-Wittgenstein eV | UNKNOWN |
| Kreisklinikum Siegen |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dyad of person with cognitive impairment and caregiver | Households identified in routine care receiving a home-based Dementia Care Management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dementia Care Management | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 months after baseline assessment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
People identified in routine care that have a cognitive impairment or live as carerer in a household with a person with cognitive impairment
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jochen René Thyrian, Prof. Dr. | German Center for Neurodegenerative Diseases (DZNE) | Principal Investigator |
| Bernhard Holle, Dr. | German Center for Neurodegenerative Diseases (DZNE) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE) | Greifswald | Mecklenburg-Vorpommern | 17489 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37612103 | Result | Purwins D, Fahsold A, Quasdorf T, Berthold H, Klas T, Albers B, Seidel K, Haberstroh J, Holle B. Implementation of dementia care management in routine care (RoutineDeCM): a study protocol for process evaluation. BMJ Open. 2023 Aug 23;13(8):e072185. doi: 10.1136/bmjopen-2023-072185. | |
| 38836294 | Result | Seidel K, Rupp L, Thyrian JR, Haberstroh J. Adapting Dementia Care Management to a Regional German Context: Assessment of Changes in Acceptability, Appropriateness, and Feasibility. J Appl Gerontol. 2024 Dec;43(12):1985-1996. doi: 10.1177/07334648241258024. Epub 2024 Jun 5. |
Not provided
Not provided
We will share data upon reasonable request and only aggregated data
data will become available after end of project - approx. 1/25
upon reasonable request to the responsible study investigator
Not provided
Not provided
| UNKNOWN |
| Caritasverband Siegen-Wittgenstein eV | UNKNOWN |
Not provided
Not provided
Not provided
| 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) | 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). | 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). | 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. | 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. | 12 months after baseline assessment |
| 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. | 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. | 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. | 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. | 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. | 12 months after baseline assessment |
| University of Siegen |
| Siegen |
| North Rhine-Westphalia |
| 57068 |
| Germany |
| Caritasverband Siegen-Wittgenstein eV | Siegen | North Rhine-Westphalia | 57072 | Germany |
| Alzheimer Gesellschaft Siegen-Wittgenstein eV | Siegen | North Rhine-Westphalia | 57076 | Germany |
| Kreisklinikum Siegen, Kliniken für Neurologie und Psychiatrie | Siegen | North Rhine-Westphalia | 57076 | Germany |
| Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE) | Witten | North Rhine-Westphalia | 58453 | Germany |
| 35564877 | Result | Seidel K, Quasdorf T, Haberstroh J, Thyrian JR. Adapting a Dementia Care Management Intervention for Regional Implementation: A Theory-Based Participatory Barrier Analysis. Int J Environ Res Public Health. 2022 Apr 30;19(9):5478. doi: 10.3390/ijerph19095478. |
| 38926143 | Derived | Thyrian JR, Boekholt M, Boes C, Grond M, Kremer S, Herder-Peyrounette A, Seidel K, Theile-Schurholz A, Haberstroh J. Implementing Dementia Care Management into routine care: protocol for a cohort study in Siegen-Wittgenstein, Germany (RoutineDeCM). BMJ Open. 2024 Jun 26;14(6):e085852. doi: 10.1136/bmjopen-2024-085852. |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D003072 | Cognition Disorders |
Not provided
Not provided