- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
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:
- Preparation
- Forward Translation
- Reconciliation
- Back Translation
- Back Translation Review
- Harmonization
- Cognitive Debriefing
- Review of Cognitive Debriefing Results and Finalization
- Proofreading
- Final Report
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Berlin, Germany, 13353
- Department of Anesthesiology and Operaitve Intensive Care Medicine, Campus Charite Mitte (CCM) and Campus Virchow - Klinikum, Charite - Universitätsmedizin Berlin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of respondents who rate the questionnaire as "applicable" or "not applicable"
Time Frame: Up to one month
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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.
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Up to one month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Up to one month
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Mean/Median applicability of the entire survey
Time Frame: Up to one month
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Mean/Median applicability of the entire survey will be calculated using the applicability ratings of the entire survey (as described above)
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Up to one month
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Frequency of limiting factors of the entire Addenbrooke's Cognitive Examination - III questionnaire
Time Frame: Up to one month
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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
|
Up to one month
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Frequency of limiting factors of the single items
Time Frame: Up to one month
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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.
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Up to one month
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACE-III
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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