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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

Tracking Information
First Submitted Date July 2, 2019
First Posted Date July 9, 2019
Last Update Posted Date October 30, 2019
Actual Study Start Date February 1, 2018
Actual Primary Completion Date July 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: July 4, 2019)
  • Amsterdam IADL Questionnaire short German version [ Time Frame: Baseline ]
    Impairment in instrumental activities of daily living (based on trait score (IRT))
  • 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 trait score IRT))
Change History Complete list of historical versions of study NCT04012398 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 8, 2019)
  • 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.
  • 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.
  • 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
  • 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".
  • 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
Original Secondary Outcome Measures
 (submitted: July 4, 2019)
  • Mini Mental State Examination [ Time Frame: Baseline ]
    Assessment of global cognition
  • Cumulative Dementia Rating [ Time Frame: Baseline ]
    Assessment to stage severity of dementia
  • 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
  • Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE) [ Time Frame: Baseline ]
    Assessment to detect and stage severity of dementia
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of the German Version of the Amsterdam Instrumental Activities of Daily Living Questionnaire®
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
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.

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
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Elderly community-dwelling people with normal cognition, mild cognitive impairment or mild dementia
Condition
  • Mild Cognitive Impairment
  • Mild Dementia
Intervention Diagnostic Test: Amsterdam IADL Questionnaire short, German version
Questionnaire to assess impairments in instrumental activities of daily living
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 28, 2019)
96
Original Estimated Enrollment
 (submitted: July 4, 2019)
100
Actual Study Completion Date September 30, 2019
Actual Primary Completion Date July 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04012398
Other Study ID Numbers A-IADL-G Validation
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Marina Bruderer, Zurich University of Applied Sciences
Study Sponsor Zurich University of Applied Sciences
Collaborators Not Provided
Investigators
Principal Investigator: Karin Niedermann, PhD Zurich University of Applied Sciences Zurich
PRS Account Zurich University of Applied Sciences
Verification Date October 2019