NCT05529277

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

2.1 years

First QC Date

August 26, 2022

Last Update Submit

June 7, 2024

Conditions

DementiaDementia AlzheimersMild Cognitive ImpairmentCare Management

Outcome Measures

Primary Outcomes (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 person with dementia (PwD), medical aids). Adding the needs indicated provides a number of unmet needs.

    6 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 PwD, medical aids). Adding the needs indicated provides a number of unmet needs.

    12 months after baseline assessment

Secondary Outcomes (6)

  • Antidementia drug treatment

    12 months after baseline assessment

  • Antidementia drug treatment

    6 months after baseline assessment

  • Neuropsychiatric Symptoms

    6 months after baseline assessment

  • Neuropsychiatric Symptoms

    12 months after baseline assessment

  • Caregiver Burden

    6 months after baseline assessment

  • +1 more secondary outcomes

Other Outcomes (6)

  • cognition

    6 months after baseline assessment

  • cognition

    12 months after baseline assessment

  • frailty

    6 months after baseline assessment

  • +3 more other outcomes

Study Arms (1)

Dyad of person with cognitive impairment and caregiver

Households identified in routine care receiving a home-based Dementia Care Management.

Other: Dementia Care Management

Interventions

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

Dyad of person with cognitive impairment and caregiver

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)

Greifswald, Mecklenburg-Vorpommern, 17489, Germany

Location

University of Siegen

Siegen, North Rhine-Westphalia, 57068, Germany

Location

Caritasverband Siegen-Wittgenstein eV

Siegen, North Rhine-Westphalia, 57072, Germany

Location

Alzheimer Gesellschaft Siegen-Wittgenstein eV

Siegen, North Rhine-Westphalia, 57076, Germany

Location

Kreisklinikum Siegen, Kliniken für Neurologie und Psychiatrie

Siegen, North Rhine-Westphalia, 57076, Germany

Location

Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE)

Witten, North Rhine-Westphalia, 58453, Germany

Location

Related Publications (4)

  • 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.

    PMID: 37612103RESULT

  • 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.

    PMID: 38836294RESULT

  • 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.

    PMID: 35564877RESULT

  • 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.

    PMID: 38926143DERIVED

MeSH Terms

Conditions

DementiaAlzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesCognition Disorders

Study Officials

  • Jochen René Thyrian, Prof. Dr.

    German Center for Neurodegenerative Diseases (DZNE)

    PRINCIPAL INVESTIGATOR

  • Bernhard Holle, Dr.

    German Center for Neurodegenerative Diseases (DZNE)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2022

First Posted

September 7, 2022

Study Start

September 1, 2022

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

June 10, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

We will share data upon reasonable request and only aggregated data

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
data will become available after end of project - approx. 1/25
Access Criteria
upon reasonable request to the responsible study investigator

Locations

DE(6)