Clinical trial NCT05529277: Implementing Dementia Care Management Into Routine Care in the Region Siegen-Wittgenstein
Official title: Dementia Care Management in Der Routineversorgung am Beispiel Der Region Siegen-Wittgenstein (RoutineDeCM)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dementia
Dementia Alzheimers
Mild Cognitive Impairment
Care Management
Lead sponsor: German Center for Neurodegenerative Diseases (DZNE)
Sponsor class: OTHER
Collaborators: name: University of Siegen
name: Gesundheitsregion Siegerland eG (GRS)
name: Alzheimer Gesellschaft Siegen-Wittgenstein eV
name: Kreisklinikum Siegen
name: Caritasverband Siegen-Wittgenstein eV
First posted: 2022-09-07
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: unmet needs
timeFrame: 6 months after baseline assessment
measure: unmet needs
timeFrame: 12 months after baseline assessment
Secondary outcomes:
measure: Antidementia drug treatment
timeFrame: 12 months after baseline assessment
measure: Antidementia drug treatment
timeFrame: 6 months after baseline assessment
measure: Neuropsychiatric Symptoms
timeFrame: 6 months after baseline assessment
measure: Neuropsychiatric Symptoms
timeFrame: 12 months after baseline assessment
measure: Caregiver Burden
timeFrame: 6 months after baseline assessment
measure: Caregiver Burden
timeFrame: 12 months after baseline assessment
Other outcomes:
measure: cognition
timeFrame: 6 months after baseline assessment
measure: cognition
timeFrame: 12 months after baseline assessment
measure: frailty
timeFrame: 6 months after baseline assessment
measure: frailty
timeFrame: 12 months after baseline assessment
measure: (health-related) quality of life
timeFrame: 6 months after baseline assessment
measure: (health-related) quality of life
timeFrame: 12 months after baseline assessment
Locations:
city: Greifswald
country: Germany
facility: Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)
state: MV
city: Siegen
country: Germany
facility: University of Siegen
state: NRW
city: Siegen
country: Germany
facility: Caritasverband Siegen-Wittgenstein eV
state: NRW
city: Siegen
country: Germany
facility: Alzheimer Gesellschaft Siegen-Wittgenstein eV
state: NRW
city: Siegen
country: Germany
facility: Kreisklinikum Siegen, Kliniken für Neurologie und Psychiatrie
state: NRW
city: Witten
country: Germany
facility: Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)
state: NRW
Study officials:
affiliation: German Center for Neurodegenerative Diseases (DZNE)
name: Jochen René Thyrian, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: German Center for Neurodegenerative Diseases (DZNE)
name: Bernhard Holle, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.