Trial document




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  DRKS00012765

Trial Description

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Title

Modular measuring systems for the individual therapy and care of dementia patients

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Trial Acronym

Pyramid

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URL of the Trial

http://www.pyramid-demenzprojekt.de

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Brief Summary in Lay Language

The main objective of the study is the investigation of requirements for a technical assistance system for people with dementia. They should thus be enabled to maintain an independent and self-determined lifestyle in their home environment for a longer time. The aim is to find out which requirements are named for this by the study participants - dementia sufferers and their social reference persons. The hypothesis is that an assistance system can support dementia sufferers.

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Brief Summary in Scientific Language

Study on the requirements for a technical assistance system for persons with impairment of cognitive performance in order to maintain an independent and self-determined lifestyle in the home environment for longer. Participants are dementia sufferers and their social reference persons. The aim is to find out which requirements are defined by the different study participants. The hypothesis is that an assistance system can support dementia sufferers.

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Organizational Data

  •   DRKS00012765
  •   2017/10/25
  •   [---]*
  •   yes
  •   Approved
  •   EA1/171/17, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F00 -  Dementia in Alzheimer disease
  •   F01 -  Vascular dementia
  •   F02 -  Dementia in other diseases classified elsewhere
  •   F03 -  Unspecified dementia
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Interventions/Observational Groups

  •   Dementia sufferers and their social reference persons are questioned once using a questionnaire on the use of technical assistance systems
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Which subjectively and objectively measurable indicators are necessary to support persons with cognitive impairments in the life day with a technical assistance system?

The data are collected with a standardized questionnaire.

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Secondary Outcome

Which parameters are used by cognitively impaired persons and their social reference persons (eg relatives, caregivers and nurses), so that a technical measuring system provides support in everyday life with the aim of the long-term independent and self-determined life-cycle of dementia patients?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2017/10/26
  •   560
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Early to middle stages of cognitive disorders, patients with rheumatic diseases, relatives, reference persons

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Exclusion Criteria

Later disease stages of dementia or cognitive impairments, which lead to non-acceptance,
Non-compliant, protected persons,
Psychiatric disorder, which limits the understanding of the project plan (not consentable),
Prisoner or a person who is placed in a clinic by an administrative or judicial order.

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Addresses

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    • Charité – Universitätsmedizin Berlin, Klinik m.S. Rheumatologie und Klinische Immunologie CC12
    • Mr.  Prof. Dr.  Gerd R.  Burmester 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité – Universitätsmedizin Berlin, Klinik m.S. Rheumatologie und Klinische Immunologie CC12
    • Ms.  Dr. med.  Jacqueline  Detert 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Studiengruppe Insider, Charité – Universitätsmedizin Berlin, Klinik m.S. Rheumatologie und Klinische Immunologie CC12
    • Mr.  Axel  Steinbach 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Hannoversche Straße 28-30
    • 10115  Berlin
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.