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

Active, not recruiting

• Conditions: Dementia Alzheimers; Dementia; Care Management; Mild Cognitive Impairment
• Interventions: Other: Dementia Care Management

• Registration Number: NCT05529277
• Lead Sponsor: German Center for Neurodegenerative Diseases (DZNE)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-26
• Study Start: 2022-09-01
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dyad of person with cognitive impairment and caregiver	Dementia Care Management	Households identified in routine care receiving a home-based Dementia Care Management.

Primary Outcome Measures

Name	Time	Method
unmet needs	12 months after baseline assessment	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.

Secondary Outcome Measures

Name	Time	Method
Antidementia drug treatment	6 months after baseline assessment	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)
Neuropsychiatric Symptoms	12 months after baseline assessment	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).
Caregiver Burden	12 months after baseline assessment	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.

Trial Locations

Locations (5)

University of Siegen; 🇩🇪 Siegen, NRW, Germany

Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE); 🇩🇪 Witten, NRW, Germany

Caritasverband Siegen-Wittgenstein eV; 🇩🇪 Siegen, NRW, Germany

Alzheimer Gesellschaft Siegen-Wittgenstein eV; 🇩🇪 Siegen, NRW, Germany

Kreisklinikum Siegen, Kliniken für Neurologie und Psychiatrie; 🇩🇪 Siegen, NRW, Germany