Trial document




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  DRKS00003957

Trial Description

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Title

Geriatric-psychiatric house calls and counseling in Düsseldorf for people with dementia and loss of insight

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Trial Acronym

GerHaRD

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URL of the Trial

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Brief Summary in Lay Language

The project GerHaRD focuses on patients with dementia and anosognosia, who previously rejected medical assistance and support. Subjects will be visited at home together with caregivers and relatives by an experienced geriatric psychiatrist and members of the residential dementia network. In addition to a preliminary diagnostic assessment the caregivers and relatives will be informed on specific institutional and non-institutional support. Primary aim is to integrate subjects into a residential network and to facilitate domestic care as long as possible.

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Brief Summary in Scientific Language

Anosognosia is a common symptom in dementia, covering a wide spectrum from loss of insight till denial of illness. Anosognosia has significant impact on the course of the disease and is associated with unfavourable outcome. Due to unawareness the patient is not able to initiate medical evaluation and to accept diagnostic procedures or medical treatment. Thus, patients are not integrated into psycho-social networks and medical support. This has significant impact on patient-centered-care in a domestic environment.

New strategies are required to cope with anosognosia in patients with dementia and their caregivers. Medical advice and home-counseling need to be developed for the German Health Care System as a tool for low-threshold-approach. The scientific aim of the current investigation is the evaluation of interventions to integrate patients with dementia and anosognosia into the existing residential facilities for patients with dementia. Study population are patients with dementia and significant unawareness as well as caregivers or other relatives of subjects, who had denied to join medical evaluation deliberately till now. Subjects are visited at home assisted by caregivers and relatives.

Aims of the study:
1. Describing a subgroup of patients with dementia and anosognosia, which has not received much interest in previous scientific work until today.
2. Collecting sociodemographic data as well as information on the severity of dementia and subjective burden of disease of the caregivers due to anosognosia. Use of standardized rating instruments.
3. Distributing specific information on dementia and strategies to cope with behavourial alterations to the caregivers .
4. Initiation of guideline-based diagnosis and treatment by general practitioners. A written report will be submitted to a general practitioner, if available.
5. A specific training program for caregivers to cope with unawareness will be developed.
6. Evaluation of the intervention 12 months later. An interview by phone call will be performed with caregivers regarding the established supporting aids.

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Organizational Data

  •   DRKS00003957
  •   2012/07/16
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  •   yes
  •   Approved
  •   3695 , Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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Health Condition or Problem studied

  •   F00.1 -  Dementia in Alzheimer's disease with late onset
  •   F00.2 -  Dementia in Alzheimer's disease, atypical or mixed type
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Interventions/Observational Groups

  •   People suffering from dementia and anosognosia and their relatives are visited in their homes by a medical specialist and a member of the staff of the Düsseldorf dementia network.
    A first diagnostic evaluation is made; individual advice on treatment and local assistance services is given.
    During the home visits, the following assessment instruments are used for detailed documentation:

    • Anamnesis or heteroanamnesis
    • psychopathological diagnosis (on the basis of the AMDP system)
    • Geriatric Deterioration Scale (GDS) to determine the severity code
    • Mini-mental state examination (MMSE) to screen cognitive impairment
    • Barthel-scale and NOSGER to measure the patient's functional status
    • COPE-Index and Anosognosia Questionnaire in Dementia (AQ-D) as specific measures to survey self-perception
    • Assistance that was established before the house call (such as contact with the local general social services, nursing service, domestic service, meal delivery service, and so on)
    • Interventions or measures that are proposed by the GerHaRD staff and for whose implementation the patients and their families will receive further assistance.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
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Primary Outcome

integration into the local health care system, 1) result of the intervention after house call: result sheet "house call"
--> individual suggestion adressed to the general practitioner
-for the use of care services (yes/no)
-and a specific medical treatment (yes/no)
2) follow-up after 12 month by using a standardized telephone interview:
-established use of care services (yes/no)
-established specific medical treatment (yes/no)

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Secondary Outcome

- cognitive status, assessed uniquely with Mini-Mental-Status-Examination (MMSE) and Clock Drawing Test (CDT)
- everyday-competence, assessed uniquely with Nurses observation scale for geriatric Patients (NOSGER)
- stage of dementia, assessed uniquely with geriatric deterioration scale (GDS)
- burden of caring relatives, assessed uniquely with the COPE-index
- awareness of illness, assessed uniquely with Anosognosia-Questionnaire for Dementia AQ-D (discrepancy between the patients and relatives information)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/07/17
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with any type of dementia and unawareness with subsequent rejection of medical evaluation.
- Age 50 years and older
- Residents of the city of Düsseldorf

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Exclusion Criteria

- Suicidal or potential aggressive behavior
- Cognitive disorders not due to dementia
- Severe somatic disorders requiring immediate hospitalization
- Already completed diagnostic assessment of the dementia syndrome and established medical treatment
- Rejection of any contact to the service

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Addresses

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    • Abteilung Gerontopsychiatrie LVR-Klinikum Düsseldorf/ Kliniken der Heinrich-Heine-Universität Düsseldorf
    • Mr.  Prof.  Tillmann  Supprian 
    • Bergische Landstraße 2
    • 40629  Düsseldorf
    • Germany
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    • Leitung Institutsambulanz Gerontopsychiatrie LVR-Klinikum Düsseldorf/ Kliniken der Heinrich-Heine-Universität Düsseldorf
    • Ms.  Dr. med./ Dipl. Psych.  Barbara  Höft 
    • Bergische Landstraße 2
    • 40629  Düsseldorf
    • Germany
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    • Leitung Institutsambulanz Gerontopsychiatrie LVR-Klinikum Düsseldorf/ Kliniken der Heinrich-Heine-Universität Düsseldorf
    • Ms.  Dr. med./ Dipl. Psych.  Barbara  Höft 
    • Bergische Landstraße 2
    • 40629  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Landeshauptstadt Düsseldorf Der Oberbürgermeister Amt für Soziale Sicherung und Integration Geschäftsstelle Seniorenbeirat
    • Willi_Becker-Allee 8
    • 40227  Düsseldorf
    • Germany
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    • LVR-Dezernat Gesundheit und Heilpädagogisches Netzwerk LVR-Amt für Klinikplanung Dezernat 8
    • 50663  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/12/31
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Trial Publications, Results and other Documents

  •   Paper submitted
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