Trial document





This trial has been registered retrospectively.
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  DRKS00019114

Trial Description

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Title

Testing the equivalence/non-inferiority of the digital versus the paper-based measurement method of cognitive impairments

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Trial Acronym

Intera-KT-Equivalence

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URL of the Trial

https://geriatrie.charite.de/forschung/ag_alter_technik/intera_kt/

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Brief Summary in Lay Language

The object of this study is to demonstrate the equivalence/non-inferiority of the digital assessment method compared to the conventional paper-based assessment method of established test procedures used in the diagnosis of cognitive impairment (e.g. in the context of dementia).

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Brief Summary in Scientific Language

The object of this two-armed study is to demonstrate the equivalence/non-inferiority of the digital survey method compared to the conventional paper-based variant of established test procedures used in the diagnosis of cognitive impairment (e.g. in the context of dementia, after strokes or brain injuries).

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

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00019114
  •   2019/11/28
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  •   yes
  •   Approved
  •   EA1/201/19, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   U51 -  [---]*
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Interventions/Observational Groups

  •   The cognitive performance of inpatient geriatric patients is assessed using the Mini-Mental State Test, the Extended Barthel-Index as well as DIA-S (Depression in the Elderly Scale) or GDS (Geriatric Depression Scale): Tablet/TabletPen or Paper/Pencil-based (RCT)
    Tests are conducted as part of the in-patient admission interview (each lasting approx. 1 hour). All three test procedures are performed on each patient (according to individual decision).
    Duration of testing October 2019 to April 2020.

  •   The cognitive performance of healthy seniors is examined with the Trail Making Test A/B, Clock-Drawing Test and the Rey-Osterrieth Complex Figure Test: with digitized paper/SmartPen and paper/pencil-based (Crossover-Design, randomized).
    Tests are carried out with participants within the framework of participant tests (duration approx. 1 hour each). All three test procedures are performed with each subject (randomized, either digital or paper-based).
    Duration of testing October to December 2019.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Arm 1: Mini-Mental Status Test (inpatient geriatric patients)
Arm 2: Trail Making Test A/B, Clock-Drawing Test, Rey Osterrieth Complex Figure Test (healthy seniors)

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Secondary Outcome

Arm 1: Extended Barthel-Index, Depression in the Elderly Scale, Geriatric Depression Scale (inpatient geriatric patients)

Arm 2: none (healthy seniors)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/10/21
  •   245
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Arm 1 (inpatient geriatric patients): Age ≥ 65 years, presence of patient information and signed informed consent.


Arm 2 (healthy seniors): Age ≥ 65 years, capacity for consent, presence of subject information and signed informed consent.

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Exclusion Criteria

Arm 1 (inpatient geriatric patients): legal representative.


Arm 2 (healthy seniors): severe cognitive disorders, psychiatric disorders, severe auditory, visual, linguistic, sensory or motoric impairments, severe systemic diseases, mild or severe pain, CNS diseases and diseases affecting the CNS, cerebrovascular disease, current study participation.

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Addresses

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    • Charité - Universitätsmedizin BerlinForschungsgruppe Geriatrie
    • Ms.  Dr.  Anika  Steinert 
    • Reinickendorfer Straße 61
    • 10117  Berlin
    • Germany
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    • Evangelisches Geriatriezentrum Berlin
    • Reinickendorfer Straße 61
    • 13347  Berlin
    • Germany
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    •   [---]*
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    • Charité - Universitätsmedizin BerlinForschungsgruppe Geriatrie
    • Ms.  Dr.  Anika  Steinert 
    • Reinickendorfer Straße 61
    • 13347  Berlin
    • Germany
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    • Charité - Universitätsmedizin BerlinForschungsgruppe Geriatrie
    • Ms.  Dr.  Anika  Steinert 
    • Reinickendorfer Straße 61
    • 13347  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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