Mild Cognitive ImpairmentNCT04012398
Validation of the German Version of the Amsterdam Instrumental Activities of Daily Living Questionnaire®
An observational study of Mild Cognitive Impairment and Mild Dementia, run by Zurich University of Applied Sciences at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Mild Dementia
- What is being tested?
- Amsterdam IADL Questionnaire short, German version
- How many people
- 96 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2018to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Elderly community-dwelling people with normal cognition, mild cognitive impairment or mild dementia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Memory Clinic, Geriatrische Klinik St.Gallen
Sankt Gallen, 9000
About this study
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
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.
Read the 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
- Conditions
- Mild Cognitive Impairment, Mild Dementia
- Being tested
- Amsterdam IADL Questionnaire short, German version
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amsterdam IADL Questionnaire short, German versionDiagnostic test
Questionnaire to assess impairments in instrumental activities of daily living
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Follow-up after two to four weeks
Secondary outcomes (5)
Mini Mental State Examination
Assessment of global cognition. The summary score ranges from 0 to 30 with higher scores indicating better performance.
Measured: Baseline
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.
Measured: Baseline
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
Measured: Baseline
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".
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Feb 2018
- Primary completion30 Jul 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Bruderer, Zurich University of Applied Sciences
- Investigators
- Karin Niedermann, PhD, Principal investigator, Zurich University of Applied Sciences Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012398
- Sponsor's protocol ID
- A-IADL-G Validation
- Status last verified
- Oct 2019
- First submitted
- 2 Jul 2019
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33008394
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04012398
- Acronym / sponsor ID
- A-IADL-G Validation
- Conditions
- Mild Cognitive Impairment, Mild Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly community-dwelling people with normal cognition, mild cognitive impairment or mild dementia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amsterdam IADL Questionnaire short, German versionQuestionnaire to assess impairments in instrumental activities of daily living | Diagnostic test | – |
Primary outcome
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.
5 secondary outcomes
Mini Mental State Examination
Time frame: Baseline
Cumulative Dementia Rating
Time frame: Baseline
Lawton Brody Instrumental Activities of Daily Living Scale
Time frame: Baseline
Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE) short
Time frame: Baseline
Depression im Alter Scale (DIA-S)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Derived from this study: PubMed 33008394Bruderer-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Niedermann, PhD principal investigator
Zurich University of Applied Sciences Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Mild Dementia, run by Zurich University of Applied Sciences at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amsterdam IADL Questionnaire short German version (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04012398, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.