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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dementia; Mild Cognitive Impairment; Dementia Alzheimers; Care Management
• Intervention / Treatment: Other: Dementia Care Management

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Jochen René Thyrian, Prof. Dr.; Phone Number: 7592 +49383486; Email: rene.thyrian@dzne.de
• Study Contact Backup: Name: Melanie Boekholt; Phone Number: 7593 +49383486; Email: melanie.boekholt@dzne.de

Study Locations

• Germany
  • MV
    • Greifswald, MV, Germany, 17489
      • Active, not recruiting
      • Deutsches Zentrum fur Neurodegenerative Erkrankungen (DZNE)
  • NRW
    • Siegen, NRW, Germany, 57068
      • Active, not recruiting
      • University of Siegen
    • Siegen, NRW, Germany, 57072
      • Recruiting
      • Caritasverband Siegen-Wittgenstein eV
      • Contact: Charlotte Boes
      • Principal Investigator: Charlotte Boes
    • Siegen, NRW, Germany, 57076
      • Recruiting
      • Alzheimer Gesellschaft Siegen-Wittgenstein eV
      • Contact: Stefanie Kremer
      • Principal Investigator: Stefanie Kremer
    • Siegen, NRW, Germany, 57076
      • Recruiting
      • Kreisklinikum Siegen, Kliniken für Neurologie und Psychiatrie
      • Contact: Martin Grond, Prof.Dr.
      • Principal Investigator: Martin Grond, Prof. Dr.
    • Witten, NRW, Germany, 58453
      • Active, not recruiting
      • Deutsches Zentrum fur Neurodegenerative Erkrankungen (DZNE)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People identified in routine care that have a cognitive impairment or live as carerer in a household with a person with cognitive impairment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dyad of person with cognitive impairment and caregiver; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 PwD, medical aids). Adding the needs indicated provides a number of unmet needs.	12 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 person with dementia (PwD), medical aids). Adding the needs indicated provides a number of unmet needs.	6 months after baseline assessment

Secondary Outcome Measures

Outcome Measure	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)	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
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
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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: German Center for Neurodegenerative Diseases (DZNE)
• Collaborators: University of Siegen; Gesundheitsregion Siegerland eG (GRS); Alzheimer Gesellschaft Siegen-Wittgenstein eV; Kreisklinikum Siegen; Caritasverband Siegen-Wittgenstein eV
• Investigators: Principal Investigator: Jochen René Thyrian, Prof. Dr., German Center for Neurodegenerative Diseases (DZNE); Principal Investigator: Bernhard Holle, Dr., German Center for Neurodegenerative Diseases (DZNE)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: September 1, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Cognition Disorders; Dementia; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: GR025; ZMI1-2521FSB907 (Other Grant/Funding Number: Federal Ministery of Health (BMG)); BB110/22 (Other Identifier: Ethics Comittee of the Universitymedicine Greifswald)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share data upon reasonable request and only aggregated data
• IPD Sharing Time Frame: data will become available after end of project - approx. 1/25
• IPD Sharing Access Criteria: upon reasonable request to the responsible study investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No