Clinical trial NCT05403814: Test and Usability of Mixed-reality Screening Tool for Early Detection of Cognitive Declines
Official title: Mixed Reality Prototype of Multimodal Screening for Early Detection of Cognitive Impairments in Elderly: Protocol Development and Usability Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aging
Cognitive Change
Keywords: mixed reality
multimodal screening
cognitive impairment
smart cognition
Lead sponsor: FH Joanneum Gesellschaft mbH
Sponsor class: INDUSTRY
First posted: 2022-06-03
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Residents of the city of Graz and Graz suburbs

Brief summary: The aim of this study as part of the SCOBES-AR project is to establish and test a protocol for implementation and usability of mixed reality-enhanced multidisciplinary screening tool for early detection of cognitive impairments in the elderly.

Detailed description: Early diagnosis of cognitive impairments is an important step in the adequate management of dementia. The project "Smart Cognition \& Behavior Screening powered by Augmented Reality" (SCOBES-AR) aims to develop a multimodal screening tool (MST) for early detection of cognitive impairments using augmented and virtual reality. In the first project phase validated assessments were selected, combined in MST and tested in 174 healthy elderly adults. In the present project phase, the developed MST will be partly enhanced by mixed reality (MR). This MR-enhanced prototype of screening tool (MR-MST) will be tested and compared to the previously developed MST. In addition, the usability of this enhanced prototype will be examined.

The study aims to establish a protocol for implementation and usability of MR-enhanced multidisciplinary screening tool for early detection of cognitive impairments in the elderly.

In this cross-over design study protocol 100 healthy participants (aged 60-75years) will be screened for cognitive declines using: i) specially developed MST (assessment of cognitive functions, olfactory sensitivity, nutritional preferences, gait parameters, reaction times, activities of daily living, and ii) MR-enhanced MST in which the assessments of cognitive functions, reaction time, activities of daily living and gait are performed using tailor made software and augmented reality and virtual reality hardware. The results of the MR-enhanced MST will be compared with those without MR. The usability of the developed MR-enhanced MST will be tested on 10 investigators and 10 test participants using observed summative evaluation and the co-discovery method and on 2 usability experts using the co-discovery method.

This study was funded by the Austrian Research Promotion Agency and received Ethic Vote from the Ethic committee of the Medical University of Graz. The MR-MST prototype and the study protocol for the present study were developed. To date, no results are available for this study protocol.

The development of the MR-MST prototype enables identifying best practise procedure for evaluating cognitive declines in the elderly using multimodal and MR-enhanced model.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals aged 60-75 years
* Interest in participating in the study
* Signed written informed consent form

Exclusion Criteria:

* Clinical diagnosis of mild cognitive impairment or dementia
* Clinical diagnosis of mental illness (e.g. depression, psychosis)
* Reduced mobility (walking aid, wheelchair)
* Aided hearing or visual impairment
* Participation in any other cognitive training study within the last 6 months
* Present guardianship according to the provisions of the Austrian adult protection law

Primary outcomes:
measure: Brief Smell Identification Test.
timeFrame: Day 1.
measure: Food-Frequency-Index.
timeFrame: Day 1.
measure: Dementia-Detection-Test.
timeFrame: Day 1.
measure: Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment: items "mobility" and "finances", performed with pen-and-paper.
timeFrame: Day 1.
measure: Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment: items "mobility" and "finances", performed with Virtual Reality.
timeFrame: Day 1.
measure: Trail-Making Test, performed with pen-and-paper.
timeFrame: Day 1.
measure: Trail-Making Test, performed with Augmented Reality.
timeFrame: Day 1.
measure: Reaction Time Test, performed with contact plates.
timeFrame: Day 1.
measure: Reaction Time Test, performed with smartphone mobile application.
timeFrame: Day 1.
measure: Dual Task Assessments, performed with direct observation.
timeFrame: Day 1.
measure: Dual Task Assessments, performed with Augmented Reality.
timeFrame: Day 1.
Secondary outcomes:
measure: Usability evaluation using video observations.
timeFrame: Day 1.
measure: Usability evaluation using questionnaire.
timeFrame: Day 1.
Other outcomes:
Locations:
city: Graz
country: Austria
facility: FH-Joanneum
state: Styria
Study officials:
affiliation: FH Joanneum
name: Wolfgang Staubmann, MSc
role: PRINCIPAL_INVESTIGATOR
References: