Clinical trial NCT04204239: Validation Study SCOBES-AR
Official title: A Review of Test Procedures From Different Health Care Professions With Regard to Their Suitability for the Early Detection of Cognitive Impairments in Persons Aged 60 and Older: A Validation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cognitive Decline
Cognitive Deficit
Cognitive Impairment
Lead sponsor: FH Joanneum Gesellschaft mbH
Sponsor class: INDUSTRY
Collaborators: name: Austrian Research Promotion Agency
First posted: 2019-12-18
Enrollment: 300
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: Purpose of the study The purpose of this study is to evaluate five tests to see if they are suitable for the early detection of cognitive impairment in people over the age of 60. These test procedures record the movement pattern and gait pattern, the reaction time, so-called instrumental activities of daily life (e.g. shopping or preparing meals), nutritional behaviour and the relevant sense of smell. The results are compared with those of a diagnostic procedure already in use.

Detailed description: Improved living conditions and health care are making people in Austria older and older. However, OECD data show that this happens with a lower quality of life compared to other EU member states. One factor influencing the quality of life is individual functionality at the physical and cognitive levels. Physical functionality is obvious, but cognitive impairment is preceded by a long latency phase in which subtle limitations of executive functions exist. Studies have shown that early detection of dementia through screening and early intervention can make an important contribution to a favourable course of treatment. Measures of early detection and prevention for the prevention of clinical occurrence thus move into focus. Current clinical diagnostic procedures such as cerebrospinal fluid diagnostics and MRI are not suitable for population-based early detection. Augmented Reality (AR) techniques represent an innovative basis for the development of information and communication technology (ICT) based assessment procedures. Real objects are extended by means of smartphones with virtual objects and tasks as test objects of screening. Parallel measurements of multiple parameters, automatic action recording and semi-automated evaluations provide detailed results.

The project SCOBES-AR (Smart Cognition \& Behaviour Screening powered by Augmented Reality) is funded by the Austrian Research Promotion Agency (FFG) and has a maximum duration of five years (September 2023). Through the cooperation of various health science and technical study programmes (dietology, occupational therapy, health and nursing, health management in tourism/sports science laboratory, information management, speech therapy, physiotherapy) of FH JOANNEUM, a screening instrument for the early detection of neurocognitive deficits is to be developed. The aim is to establish a multimodal tool for sustainable use in the health care system. The project thus takes up the impact goals of the Austrian dementia strategy and aims to develop a multimodal screening instrument for the early detection of functional impairments (on a cognitive and physical level) in middle and old age for outpatient care. In Phase I of the project, the evidence base for a valid instrument will be developed - The focus is on assessment selection, data protection and implementation in an AR environment. The evaluation and validation of the prototype and the AR environment are carried out in phase I and phase II respectively. In Phase III, a business model for sustainable use in the health care system with possibilities in the big data area will be developed for the finalized instrument. The present study protocol only describes the validation study in phase I of the project.

• Research objectives in phase I of the project In order to realize the main goal of the project, to develop a multimodal and low-threshold screening instrument embedded in an AR environment for the early detection of functional limitations on cognitive for outpatient care, comprehensive preliminary investigations are necessary.

The validation study presented here is one of these preliminary investigations. Five test procedures are to be tested to determine whether they are suitable for the early detection of cognitive impairments in people aged 60 and over and thus whether the evidence base for a valid instrument can be established. Different functionalities such as movement pattern \& gait pattern, reaction time, instrumental activities of daily life (iADL) will be recorded and evaluated. Examples of iADLs are shopping, financial regulation, mobility or preparing meals. Nutritional behaviour is also evaluated, since, for example, adherence to a Mediterranean diet is associated with a lower risk of various age-related diseases, including dementia. Another possible predictive factor for the development of neurocognitive impairment is the decrease in olfactory performance, which is why olfactory performance is also measured. The collected data should be compared with the established test battery "Cognitive Functions Dementia" (CFD), which is widely used in neuropsychological practice, to clarify cognitive impairments and thus be validated. The combination of the collected data results in a comprehensive functional status picture of the tested persons. Due to the extensive test setting with different test items, SCOBES-AR offers a comprehensive view of the cognitive and physical functionalities of the test person. It allows the Focus on existing reserves and capacities of the test person and not on their deficits.

The results of the present validation study will be used at the end of the project to collect the above-mentioned - or similar - functionalities via assessments, which are partly implemented in an Augmented Reality environment.

* Primary hypothesis of the study The planned tests are suitable for the early detection of cognitive impairment in people over 60 years of age.
* Secondary hypotheses of the study The primary target group (people aged 60 and over) is interested in recognising functional (cognitive and physical) limitations at an early stage in order to be able to work specifically on improving them.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals aged 60-75 years
* Interested in participating in the study
* Signing a written informed consent form

Exclusion Criteria:

* Persons who are not legally competent (Austrian adult protection law)
* Clinical diagnosis of dementia or MCI (Mild Cognitive Impairment)
* Clinical diagnosis of mental illness (e.g. depression or psychosis)
* Reduced mobility (sidekick, wheelchair)
* No compensation for visual or hearing impairment
* Insufficient knowledge of German

Primary outcomes:
measure: Erlangen Test of Activities of daily living in Persons with Mild Dementia or Mild Cognitive impairment (ETAM)
timeFrame: By completing the entire test set, an average of 2 hours
measure: Brief Smell Identification Test (B-SIT)
timeFrame: By completing the entire test set, an average of 2 hours
measure: Reaction test (TDS)
timeFrame: By completing the entire test set, an average of 2 hours
measure: Dual-Task-Assessment (DTA)
timeFrame: By completing the entire test set, an average of 2 hours
measure: Mediterranean Diet Adherence Score (MEDAS)
timeFrame: By completing the entire test set, an average of 2 hours
Secondary outcomes:
measure: Cognitive Functions Dementia (CFD)
timeFrame: By completing the entire test set, an average of 2 hours
Other outcomes:
Locations:
city: Graz
country: Austria
facility: University of Applied Sciences, FH JOANNEUM
state: Styria
Study officials:
affiliation: University of Applied Sciences, FH JOANNEUM
name: Wolfgang Staubmann, BSc MSc
role: STUDY_DIRECTOR
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