Implementing Dementia Care Management Into Routine Care in the Region Siegen-Wittgenstein

Dementia Clinical Trial

— RoutineDeCM  

Official title:

Dementia Care Management in Der Routineversorgung am Beispiel Der Region Siegen-Wittgenstein (RoutineDeCM)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05529277
• Other study ID #: GR025
• Secondary ID: ZMI1-2521FSB907B
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2022
• Source: German Center for Neurodegenerative Diseases (DZNE)
• Contact: Jochen René Thyrian, Prof. Dr.
• Phone: +49383486
• Email: rene.thyrian[@]dzne.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• person with cognitive impairment living in household
• living in the region of Siegen-Wittgenstein
• written informed consent

Exclusion Criteria:

• institutionalisation of person with cognitive impairment
• lacking sufficient communication skills

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Dementia Alzheimers
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
Germany	Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)	Greifswald	MV
Germany	Alzheimer Gesellschaft Siegen-Wittgenstein eV	Siegen	NRW
Germany	Caritasverband Siegen-Wittgenstein eV	Siegen	NRW
Germany	Kreisklinikum Siegen, Kliniken für Neurologie und Psychiatrie	Siegen	NRW
Germany	University of Siegen	Siegen	NRW
Germany	Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)	Witten	NRW

Sponsors (6)

Lead Sponsor	Collaborator
German Center for Neurodegenerative Diseases (DZNE)	Alzheimer Gesellschaft Siegen-Wittgenstein eV, Caritasverband Siegen-Wittgenstein eV, Gesundheitsregion Siegerland eG (GRS), Kreisklinikum Siegen, University of Siegen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	6 months after baseline assessment
Other	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
Other	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
Other	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
Other	(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
Other	(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
Primary	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
Primary	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
Secondary	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)	12 months after baseline assessment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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