NCT04012398

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

1.5 years

First QC Date

July 2, 2019

Last Update Submit

October 28, 2019

Conditions

Mild Cognitive ImpairmentMild Dementia

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • Mini Mental State Examination

    Baseline

  • Cumulative Dementia Rating

    Baseline

  • Lawton Brody Instrumental Activities of Daily Living Scale

    Baseline

  • Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE) short

    Baseline

  • Depression im Alter Scale (DIA-S)

    Baseline

Interventions

Amsterdam IADL Questionnaire short, German versionDIAGNOSTIC_TEST

Questionnaire to assess impairments in instrumental activities of daily living

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memory Clinic, Geriatrische Klinik St.Gallen

Sankt Gallen, 9000, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 33008394DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Karin Niedermann, PhD

    Zurich University of Applied Sciences Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 9, 2019

Study Start

February 1, 2018

Primary Completion

July 30, 2019

Study Completion

September 30, 2019

Last Updated

October 30, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)