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Digital and paper-based DemTect for the detection of cognitive changes: How well do they agree and how good is the usability of the digital format?

Validation of self-administered digital DemTect for neurocognitive screening: a randomized crossover trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15891080
Enrollment
134
Registered
2023-06-09
Start date
2023-08-09
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Detection of cognitive changes (mild cognitive impairment and dementia) using DemTect - a validated neurocognitive screening instrument. Mental and Behavioural Disorders

Interventions

Since this study is a crossover trial, all participants will receive both IA-DemTect and SA-DemTect and will act as their own controls. Eligible participants will be randomly assigned in a 1:1 allocat

Sponsors

University of Zurich
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older 2. Fluent in German (reading and writing) 3. No documented neuropsychiatric disturbances influencing cognitive ability and ability to follow the study procedures 4. Have a mobile phone 5. Provided informed consent

Exclusion criteria

Exclusion criteria: All individuals not fulfilling the previously mentioned inclusion criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
Degree to which the SA- and IA-DemTect scores and sub-scores agree with each other (assessed by the intraclass correlation coefficient). SA- and IA-DemTect scores are assessed at baseline and week three.

Secondary

MeasureTime frame
1. Agreement (assessed by kappa coefficients) of SA- and IA-DemTect in the classification of cognitive impairment (none, mild and significant cognitive impairment). SA- and IA-DemTect scores are assessed at baseline and week three. 2. Agreement of the two SA-DemTect assessments scores with each other (i.e., at-home versus clinical setting), as measured at baseline or week three (depending on the allocation sequence) and week six. 3. Differences in completion times of SA- and IA-DemTect assessments, measured at baseline and week three. 4. Usability of SA-DemTect evaluated at week six using participant questionnaires, and 5. Participant preferences with regards to the SA- and IA-DemTect evaluated at week six using participant questionnaires.

Countries

Switzerland

Contacts

Public ContactTala Ballouz
tala.ballouz@uzh.ch+41 44 634 35 48

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026