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

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT03460821
Collaborator
(none)
20
1
30
20.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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:
    1. Preparation

    2. Forward Translation

    3. Reconciliation

    4. Back Translation

    5. Back Translation Review

    6. Harmonization

    7. Cognitive Debriefing

    8. Review of Cognitive Debriefing Results and Finalization

    9. Proofreading

    10. Final Report

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Validation of a German Translation and Cultural Adaptation of the Addenbrooke's Cognitive Examination III
    Actual Study Start Date :
    Mar 1, 2018
    Actual Primary Completion Date :
    Mar 31, 2018
    Actual Study Completion Date :
    Mar 31, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Employees

    Male and female employees (≥ 18 years of age) of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité Universitätsmedizin Berlin experienced in the field of neurocognitive testing: residents, specialist physician for anesthesiology, senior physicians, medical students engaged in research projects

    Outcome Measures

    Primary Outcome Measures

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 67 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology and Operaitve Intensive Care Medicine, Campus Charite Mitte (CCM) and Campus Virchow - Klinikum, Charite - Universitätsmedizin Berlin Berlin Germany 13353

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Study Director: Claudia Spies, MD, Prof., Charite University, Berlin, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Claudia Spies, Head of the Department of Anesthesiology and operative Intensive Care Medicine (CCM, CVK), Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT03460821
    Other Study ID Numbers:
    • ACE-III
    First Posted:
    Mar 9, 2018
    Last Update Posted:
    Apr 11, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 11, 2018