Neurocognitive DysfunctionNCT03460821
Validation of a German Translation and Cultural Adaptation of the Addenbrooke's Cognitive Examination III
An observational study of Neurocognitive Dysfunction, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurocognitive Dysfunction
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2018to 31 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- Insufficient knowledge of the German language
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Operaitve Intensive Care Medicine, Campus Charite Mitte (CCM) and Campus Virchow - Klinikum, Charite - Universitätsmedizin Berlin
Berlin, 13353
About this study
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.
Read the 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
- Conditions
- Neurocognitive Dysfunction
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to one month
Secondary outcomes (4)
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
Measured: Up to one month
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)
Measured: Up to one month
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
Measured: Up to one month
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.
Measured: Up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 Mar 2018
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460821
- Sponsor's protocol ID
- ACE-III
- Status last verified
- Apr 2018
- First submitted
- 27 Feb 2018
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a German Translation and Cultural Adaptation of the Addenbrooke's Cognitive Examination III
- ClinicalTrials.gov ID
- NCT03460821
- Acronym / sponsor ID
- ACE-III
- Conditions
- Neurocognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Insufficient knowledge of the German language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Percentage of the items which are rated as "applicable" or "not applicable"
Time frame: Up to one month
Mean/Median applicability of the entire survey
Time frame: Up to one month
Frequency of limiting factors of the entire Addenbrooke's Cognitive Examination - III questionnaire
Time frame: Up to one month
Frequency of limiting factors of the single items
Time frame: Up to one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognitive Dysfunction, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of respondents who rate the questionnaire as "applicable" or "not applicable" (time frame: Up to one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.