Clinical trial NCT04012398: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Mild Dementia
Lead sponsor: Zurich University of Applied Sciences
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 96
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly community-dwelling people with normal cognition, mild cognitive impairment or mild dementia

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

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

Primary outcomes:
measure: Amsterdam IADL Questionnaire short German version
timeFrame: Baseline
measure: Change from baseline on the Amsterdam IADL Questionnaire short German version at two to four weeks
timeFrame: Follow-up after two to four weeks
Secondary outcomes:
measure: Mini Mental State Examination
timeFrame: Baseline
measure: Cumulative Dementia Rating
timeFrame: Baseline
measure: Lawton Brody Instrumental Activities of Daily Living Scale
timeFrame: Baseline
measure: Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE) short
timeFrame: Baseline
measure: Depression im Alter Scale (DIA-S)
timeFrame: Baseline
Other outcomes:
Locations:
city: Saint Gallen
country: Switzerland
facility: Memory Clinic, Geriatrische Klinik St.Gallen
Study officials:
affiliation: Zurich University of Applied Sciences Zurich
name: Karin Niedermann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bruderer-Hofstetter M, Dubbelman MA, Meichtry A, Koehn F, Munzer T, Jutten RJ, Scheltens P, Sikkes SAM, Niedermann K. Cross-cultural adaptation and validation of the Amsterdam Instrumental Activities of Daily Living questionnaire short version German for Switzerland. Health Qual Life Outcomes. 2020 Oct 2;18(1):323. doi: 10.1186/s12955-020-01576-w.