Trial document




This trial has been registered retrospectively.
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  DRKS00010096

Trial Description

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Title

Effectiveness of a computer-based, personalized cognitive training program in healthy elderly individuals - a study within the "NeuroCare" project funded by the German Ministry of Education and Research (BMBF)

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Trial Acronym

NeuroVitAALis study

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URL of the Trial

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Brief Summary in Lay Language

The main aim of this study is to define cognitvie effects of a computer-based cognitive trainings program in healthy elderly individuals aged 55 or older. Furthermore, sociodemogarphic and (neuro-)psychological predictiors of training succes are analyzed.

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Brief Summary in Scientific Language

Within the multi-center project NeuroCare funded by the German Ministry of Education and Research, effects of a computer-based, personalized, cognitive training program ("NeuroVitAALis") which was developed at the University of Vechta in cooperation with the TU Darmstadt is tested.
In this randomized controlled study, 60 healthy home dwelling individuals aged 55 and over are allocated to either to the intervention group which performed the cognitive training program or an active control condition. The training includes three sessions per week over a period of six weeks.
Before and after intevention, an elaborate neuropsychological test battery is performed with each participant.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00010096
  •   2016/03/14
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  •   yes
  •   Approved
  •   01_14, Ethikkommission Uni Vechta
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Secondary IDs

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Health Condition or Problem studied

  •   Healthy elderly
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Interventions/Observational Groups

  •   Experimental group: cognitive training program which trains age-sensitive cognitive domains (memory, executive functions, attention). Participants trained three times a week (each session 45 minutes) over six weeks.
  •   Active control group: Unspecific training program with the same frequency and intensity.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Before and after the intervention:
Verbal memory (VLMT - Verbaler Lern- und Merkfähigkeitstest)
Visual memory (WMS - Wechsler Memory Scale, Visuelle Wiedergabe)
Visuo-spatial skills (LPS 50+ - Leistungsprüfsystem, subtest 9)
Attention (BTA - Brief Test of Attention)

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Secondary Outcome

Subjective memory impairment (Subjective Memory Impairment- Questionnaire), Depression (Beck Depressions Inventar-II)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • University Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2015/03/16
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   55   Years
  •   100   Years
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Additional Inclusion Criteria

Healthy independent home dwelling individuals aged between 55 and 100 years.
German as mother tongue or very good German skills.
Normal or sufficiently corrected vision and hearing ability.
Written consent to study.

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Exclusion Criteria

Cognitive impairment (MoCA < 26 points)
Depression ( BDI - II > 12 )
Current substance abuse (nicotine excluded)
Current psychiatric and/ or neurological disorders
Motor restrictions that limit the use of a computer
Life-threatening illness

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Addresses

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    • Medizinische Psychologie | Neuropsychologie & Gender Studies Uniklinik Köln & Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI), Uniklinik Köln
    • Ms.  Prof. Dr.  Elke  Kalbe 
    • Kerpenerstr. 68
    • 50937  Köln
    • Germany
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    • Medizinische Psychologie | Neuropsychologie & Gender Studies Uniklinik Köln & Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI), Uniklinik Köln
    • Ms.  Prof. Dr.  Elke  Kalbe 
    • Kerpener Str. 68
    • 50937  Köln
    • Germany
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    • Universität Vechta
    • Mr.  B. A.  Christophe  Bintener 
    • Driverstr. 22
    • 49377  Vechta
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung (BMBF), Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/10/31
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Trial Publications, Results and other Documents

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