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Completed

NCT Number: NCT03460821

Validation of a German Translation and Cultural Adaptation of the Addenbrooke's Cognitive Examination III

The aim of the entire project was to perform a translation and cultural adaptation of the Addenbrooke's Cognitive Examination - III (ACE-III), adhering to the Translation and Cultural Adaptation of Patient Reported Outcomes Measures-Principles of Good Practice, in order to make it available to German clinicians.

Part of the translation process is the cognitive debriefing which will be performed as a survey which rates the applicability of every single item as well as of the entire Addenbrooke's Cognitive Examination - III tool.

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Key information

Conditions

Neurocognitive Dysfunction Cognition Disorders Mental Disorders Neurocognitive Disorders

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Operaitve Intensive Care Medicine, Campus Charite Mitte (CCM) and Campus Virchow - Klinikum, Charite - Universitätsmedizin Berlin

Berlin, 13353, Germany

About this study

The recent demographic developments have drastically increased the importance of developing applicable approaches to the diagnostics of dementia and the general evaluation of cognitive function. Many different tests were developed to thoroughly evaluate neurocognitive function.

The Addenbrooke's Cognitive Examination, developed in 2000, was one such tests and has served as an open source neurocognitive examination tool ever since. The current version is the Addenbrooke's Cognitive Examination III (ACE-III). The aim was to develop a tool that would be able to identify dementia in its early stages and also to differentiate between the different types of dementia.

In order to achieve reliable results, cognitive tests should be conducted in a familiar language and draw from the cultural background a participant is familiar with. The ACE-III and all its predecessors were developed in English and for an English-speaking cultural background, not directly applicable to the typical German patient. This made it necessary to perform not only a verbatim translation of test contents, but also to appropriately adapt the test content to reflect the cultural background of the typical German patient. The International Society For Pharmacoeconomics and Outcomes Research (ISPOR) - Task Force for Translation and Cultural Adaptation has developed the "Translation and Cultural Adaptation of Patient Reported Outcomes Measures-Principles of Good Practice", to ensure a consistent and rigorous methodology in the process of translating and adapting patient-reported outcomes measures.

The Principles of Good Practice consist of ten steps:

  • Preparation
  • Forward Translation
  • Reconciliation
  • Back Translation
  • Back Translation Review
  • Harmonization
  • Cognitive Debriefing
  • Review of Cognitive Debriefing Results and Finalization
  • Proofreading
  • Final Report

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female employees of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité Universitätsmedizin Berlin (residents, specialist physician for anesthesiology, senior physicians, medical students engaged in research projects)

.- ≥ 18 years of age

  • Experience in the field of neurocognitive testing

Exclusion criteria

  • Insufficient knowledge of the German language

Treatment and study plan

Primary outcomes

  1. Percentage of respondents who rate the questionnaire as "applicable" or "not applicable"

    Time frame: Up to one month

    The overall applicability of the German translation will be evaluated on a scale from 0 (not applicable) to 5 (applicable without any restrictions). A priori, a score of ≥ 4 was defined as indicating applicability. The overall applicability will be judged by the amount of survey respondents rating the entire battery as applicable, in relation to the total number of respondents.

Secondary outcomes

  1. Percentage of the items which are rated as "applicable" or "not applicable"

    Time frame: Up to one month

    Description: The applicability of each individual item will be evaluated on a scale from 0 (not applicable) to 5 (applicable without any restrictions). A priori, a score of ≥ 4 was defined as indicating applicability. The overall applicability will be judged by the amount of survey respondents rating the entire battery as applicable, in relation to the total number of respondents

  2. Mean/Median applicability of the entire survey

    Time frame: Up to one month

    Mean/Median applicability of the entire survey will be calculated using the applicability ratings of the entire survey (as described above)

  3. Frequency of limiting factors of the entire Addenbrooke's Cognitive Examination - III questionnaire

    Time frame: Up to one month

    If participants rate the entire survey as not applicable (rating < 4) they are asked to choose a limiting factor from a predefined list. The frequency with which every limiting factor is mentioned is compiled to evaluate its impact on the entire survey

  4. Frequency of limiting factors of the single items

    Time frame: Up to one month

    If participants rate an item as not applicable (rating < 4) they are asked to choose a limiting factor from a predefined list. The frequency with which every limiting factor is mentioned is compiled to evaluate its impact on the entire survey.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 9, 2018
Registry last updated
Apr 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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