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DementiaRoutineDeCMNCT05529277

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

An observational study of Dementia and Dementia Alzheimers, run by German Center for Neurodegenerative Diseases (DZNE) at 6 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dementia Care Management
How many people
93 participants
Where
6 sitesGermany
Study dates
1 Sep 2022to 30 Sep 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)

    Greifswald, Mecklenburg-Vorpommern, 17489

  • University of Siegen

    Siegen, North Rhine-Westphalia, 57068

  • Caritasverband Siegen-Wittgenstein eV

    Siegen, North Rhine-Westphalia, 57072

  • Alzheimer Gesellschaft Siegen-Wittgenstein eV

    Siegen, North Rhine-Westphalia, 57076

  • Kreisklinikum Siegen, Kliniken für Neurologie und Psychiatrie

    Siegen, North Rhine-Westphalia, 57076

  • Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)

    Witten, North Rhine-Westphalia, 58453

Other trials in Germany

About this study

Official title: 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.

Read more

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.

Being tested
Dementia Care Management
Medical subject headings
Dementia, Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dementia Care ManagementOther

    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

Study groups in NCT05529277
Study groupRoleWhat they receive
Dyad of person with cognitive impairment and caregiverHouseholds identified in routine care receiving a home-based Dementia Care Management.
Receives: Other: Dementia Care Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months after baseline assessment

  2. 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.

    Measured: 12 months after baseline assessment

Secondary outcomes (6)

  1. 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)

    Measured: 12 months after baseline assessment

  2. 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)

    Measured: 6 months after baseline assessment

  3. 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).

    Measured: 6 months after baseline assessment

  4. 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).

    Measured: 12 months after baseline assessment

  5. 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.

    Measured: 6 months after baseline assessment

  6. 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.

    Measured: 12 months after baseline assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2022
  2. Study start1 Sep 2022
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion30 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05529277
Sponsor's protocol ID
GR025
Other IDs
ZMI1-2521FSB907, BB110/22
Acronym
RoutineDeCM
Status last verified
Jun 2024
First submitted
26 Aug 2022
Last updated
10 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will share data upon reasonable request and only aggregated data

Publications

  • 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.

    PubMed 37612103

  • 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.

    PubMed 38836294

  • 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.

    PubMed 35564877

  • 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.

    PubMed 38926143

Questions about this trial

What is this clinical trial studying?

An observational study of Dementia and Dementia Alzheimers, run by German Center for Neurodegenerative Diseases (DZNE) at 6 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

unmet needs (time frame: 6 months after baseline assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05529277, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.

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