- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04012398
Validation of the German Version of the Amsterdam Instrumental Activities of Daily Living Questionnaire®
Cross-cultural Validation of the German Version of the Amsterdam Instrumental Activities of Daily Living Questionnaire® in Elderly People With and Without Mild Neurocognitive Disorder
Pretest and validation of the German version of the Amsterdam instrumental activities of daily living questionaire short in elderly people with normal cognition, mild cognitive impairment (MCI) or mild dementia in the German speaking part of Switzerland.
The aim is to investigate the psychometric properties of the final Amsterdam instrumental activities of daily living questionaire short (A-IADL-Q-SV) German.
Participants with normal cognition will be recruited in the community and participants with MCI and mild dementia in three memory clinic settings.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pretest:
Initially, five clinicians in the field will be asked to give feedback on the A-IADL-Q-SV German. Issues that need to be discussed include clarity of 1) answer options 2) the gradient of difficulty 3) activities or sentences. Adjustments will be made if necessary and documented.
At least five knowledgeable informants will then complete the A-IADL-Q-SV while thinking out loud and are asked to write down comments and issues on 1) the relevance of all items, 2) the applicability / meaning of the activities in Switzerland and 3) the understandability of the questions. The results will be reviewed in order to identify whether translation modifications will be necessary (e.g. rewording of items/response options). Additionally, the completed questionnaires will be explored to detect high proportions of missing items or single responses. If adjustments will be made, they will be discussed with the developer to finalize the translated German version.
Validation:
The A-IADL-Q-SV German will be tested in the community (people with normal cognition)and three memory clinic settings (people with MCI, mild dementia) including a total of 100 informants from people with normal cognition, MCI and mild dementia.
Construct validity will be assessed whether the A-IADL-Q-SV German shows the expected correlations with the mini mental state examination (MMSE), the cumulative dementia rating (CDR), the Lawton Brody Scale, the IQCODE and the Depression im Alter scale (DIA-S) Internal consistency will be assessed using item response theory (IRT) by investigating whether the translated version fits the graded response model of the original version and whether the assumptions of IRT are still met (unidimensionality, local independence and monotonicity).
Measurement invariance will be investigated using IRT by investigating whether differential item functioning is present in the comparison of the item characteristic curves of the original and translated version.
Responsiveness will be examined whether the A-IADL-Q-SV is able to discriminate people with MCI from people with normal cognition/ mild dementia Test-Retest reliability will be assessed on item level
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Saint Gallen, Switzerland, 9000
- Memory Clinic, Geriatrische Klinik St.Gallen
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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:
- Living in the community
- Ability to understand the purpose of the study and to consent
- Knowledgeable informant available
- Signed informed consent to participate in the study
Exclusion Criteria:
- Moderate and severe cognitive decline (MMSE < 20) (people with MCI, mild dementia)
- Cognitive decline suspect based on telephone screening (people with normal cognition)
- Cognitive decline due to other causes than Alzheimer's disease, vascular dementia (e.g. neurological diseases, trauma, delirium)
- Diagnosed Depression
- Diagnosed Alcohol or Drug Misuse
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amsterdam IADL Questionnaire short German version
Time Frame: Baseline
|
Impairment in instrumental activities of daily living.
Based on item response theory (IRT) the latent trait score is calculated with a mean of zero and standard deviation of one.
The resulting score ranges from 20 to 80 with lower scores indicating poorer performance.
|
Baseline
|
Change from baseline on the Amsterdam IADL Questionnaire short German version at two to four weeks
Time Frame: Follow-up after two to four weeks
|
Impairment in instrumental activities of daily living.
Based on item response theory (IRT) the latent trait score is calculated with a mean of zero and standard deviation of one.
The resulting score ranges from 20 to 80 with lower scores indicating poorer performance.
|
Follow-up after two to four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mini Mental State Examination
Time Frame: Baseline
|
Assessment of global cognition.
The summary score ranges from 0 to 30 with higher scores indicating better performance.
|
Baseline
|
Cumulative Dementia Rating
Time Frame: Baseline
|
Assessment to stage the severity of dementia.
The scoring ranges from 0 to 3 (0 = normal; 0.5 = very mild dementia; 1 = mild dementia; 2 = moderate dementia; 3 = severe dementia).
Based on an interview (patient and / or relative) six domains of cognitive and functional performance (memory, orientation, judgment / problem solving, community affairs, home / hobbies and personal care.) are rated on a 5-point scale, based on this information the dementia rating is computed.
|
Baseline
|
Lawton Brody Instrumental Activities of Daily Living Scale
Time Frame: Baseline
|
The summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias
|
Baseline
|
Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE) short
Time Frame: Baseline
|
Assessment to detect cognitive decline.
Scores on each question (score 1 = "much better" to 5 = "much worse") are added up and devided by the number of questions.
The score ranges from 1 to 5, a score of 3 means "no change", a score of 4 means "a little worse" and a score of 5 means "much worse".
|
Baseline
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Depression im Alter Scale (DIA-S)
Time Frame: Baseline
|
The summary score ranges from 0 to 10. 0 to 2 points inconspicuous mood; > 3 points suspicious depression; > 4 points probable pathological depression
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Karin Niedermann, PhD, Zurich University of Applied Sciences Zurich
Publications and helpful links
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
- A-IADL-G Validation
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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