Validation of the German Version of the Amsterdam Instrumental Activities of Daily Living Questionnaire®

October 28, 2019 updated by: Marina Bruderer, Zurich University of Applied Sciences

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

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

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Saint Gallen, Switzerland, 9000
        • Memory Clinic, Geriatrische Klinik St.Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elderly community-dwelling people with normal cognition, mild cognitive impairment or mild dementia

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Karin Niedermann, PhD, Zurich University of Applied Sciences Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 4, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 28, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • A-IADL-G Validation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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