Neurocognitive Dysfunction Clinical Trial
Official title:
Validation of a German Translation and Cultural Adaptation of the Addenbrooke's Cognitive Examination III
Verified date | April 2018 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 31, 2018 |
Est. primary completion date | March 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 67 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Anesthesiology and Operaitve Intensive Care Medicine, Campus Charite Mitte (CCM) and Campus Virchow - Klinikum, Charite - Universitätsmedizin Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of respondents who rate the questionnaire as "applicable" or "not applicable" | 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. | Up to one month | |
Secondary | Percentage of the items which are rated as "applicable" or "not applicable" | 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 | Up to one month | |
Secondary | Mean/Median applicability of the entire survey | Mean/Median applicability of the entire survey will be calculated using the applicability ratings of the entire survey (as described above) | Up to one month | |
Secondary | Frequency of limiting factors of the entire Addenbrooke's Cognitive Examination - III questionnaire | 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 | |
Secondary | Frequency of limiting factors of the single items | 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. | Up to one month |
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