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

Mild Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012398
• Other study ID #: A-IADL-G Validation
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: Zurich University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment
• Mild Dementia

Intervention

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

Locations

Country	Name	City	State
Switzerland	Memory Clinic, Geriatrische Klinik St.Gallen	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Zurich University of Applied Sciences

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amsterdam IADL Questionnaire short German version	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
Primary	Change from baseline on the Amsterdam IADL Questionnaire short German version at 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	Mini Mental State Examination	Assessment of global cognition. The summary score ranges from 0 to 30 with higher scores indicating better performance.	Baseline
Secondary	Cumulative Dementia Rating	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
Secondary	Lawton Brody Instrumental Activities of Daily Living Scale	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
Secondary	Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE) short	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
Secondary	Depression im Alter Scale (DIA-S)	The summary score ranges from 0 to 10. 0 to 2 points inconspicuous mood; > 3 points suspicious depression; > 4 points probable pathological depression	Baseline