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

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ClinicalTrials.gov Identifier: NCT04012398
Recruitment Status : Completed
First Posted : July 9, 2019
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Marina Bruderer, Zurich University of Applied Sciences

Brief Summary:

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.


Condition or disease Intervention/treatment
Mild Cognitive Impairment Mild Dementia Diagnostic Test: Amsterdam IADL Questionnaire short, German version

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


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Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: 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
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : July 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia


Intervention Details:
  • Diagnostic Test: Amsterdam IADL Questionnaire short, German version
    Questionnaire to assess impairments in instrumental activities of daily living


Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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".

  5. 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



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Elderly community-dwelling people with normal cognition, mild cognitive impairment or mild dementia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04012398


Locations
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Switzerland
Memory Clinic, Geriatrische Klinik St.Gallen
Saint Gallen, Switzerland, 9000
Sponsors and Collaborators
Zurich University of Applied Sciences
Investigators
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Principal Investigator: Karin Niedermann, PhD Zurich University of Applied Sciences Zurich

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Responsible Party: Marina Bruderer, Principal Investigator, Zurich University of Applied Sciences
ClinicalTrials.gov Identifier: NCT04012398     History of Changes
Other Study ID Numbers: A-IADL-G Validation
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Neurocognitive Disorders
Mental Disorders
Cognition Disorders