Validation Study SCOBES-AR

NCT04204239 | Unknown

• 1 other identifier: Validation study SCOBES-AR
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Decline; Cognitive Deficit; Cognitive Impairment

Outcome Measures

Primary Outcomes (5)

• Erlangen Test of Activities of daily living in Persons with Mild Dementia or Mild Cognitive impairment (ETAM)

  For three Items the performance is evaluated on a seven-level scale (0-6 points). The execution of an item is subdivided into six sub-steps so that the test persons receive one point for each error-free sub-step. A four-step scale (0-3 points) was used for two items with a less complex structure (alarm clock and tea). The total value ranges from 0-30 points.

  By completing the entire test set, an average of 2 hours

• Brief Smell Identification Test (B-SIT)

  The test person should recognize 12 different odorous substances and choose from a four-step multiple-choice question. A total odour score results from the number of correctly identified odours, whereby higher values stand for a better odour performance (\>9 recognised odours).

  By completing the entire test set, an average of 2 hours

• Reaction test (TDS)

  Eye to hand reaction, eye to leg reaction, complex reaction capability; the time required (seconds/milliseconds) for the completion is recorded.

  By completing the entire test set, an average of 2 hours

• Dual-Task-Assessment (DTA)

  Measures the influence of a cognitive task on the gait pattern. Impaired subjects show a stronger change of different gait parameters. The gait speed, cadence, stride length, stride variance and gait phases are measured.

  By completing the entire test set, an average of 2 hours

• Mediterranean Diet Adherence Score (MEDAS)

  14-Elements-Screeningtool for the evaluation of the adherence to the Mediterranean diet. The maximum score is 14 points and indicates full compliance with the Mediterranean diet.

  By completing the entire test set, an average of 2 hours

Secondary Outcomes (1)

• Cognitive Functions Dementia (CFD)

  By completing the entire test set, an average of 2 hours

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Residents of the city of Graz and Graz suburbs

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• FH Joanneum Gesellschaft mbH: lead
• Austrian Research Promotion Agency: collaborator

Study Sites (1)

University of Applied Sciences, FH JOANNEUM

Graz, Styria, 8020, Austria

RECRUITING

Related Publications (12)

• Hebestreit K, Yahiaoui-Doktor M, Engel C, Vetter W, Siniatchkin M, Erickson N, Halle M, Kiechle M, Bischoff SC. Validation of the German version of the Mediterranean Diet Adherence Screener (MEDAS) questionnaire. BMC Cancer. 2017 May 18;17(1):341. doi: 10.1186/s12885-017-3337-y.

  PMID: 28521737 BACKGROUND

• American Occupational Therapy Association (Hrsg.). (2018). Das Framework der AOTA. Gegenstandsbereich, Prozesse und Kontexte in der ergotherapeutischen Praxis. Bern: Hogrefe.

  BACKGROUND

• Doty RL, Marcus A, Lee WW. Development of the 12-item Cross-Cultural Smell Identification Test (CC-SIT). Laryngoscope. 1996 Mar;106(3 Pt 1):353-6. doi: 10.1097/00005537-199603000-00021.

  PMID: 8614203 BACKGROUND

• Hendry K, Quinn TJ, Evans JJ, Stott DJ. Informant single screening questions for delirium and dementia in acute care--a cross-sectional test accuracy pilot study. BMC Geriatr. 2015 Feb 25;15:17. doi: 10.1186/s12877-015-0016-1.

  PMID: 25885022 BACKGROUND

• Hunter SW, Divine A, Frengopoulos C, Montero Odasso M. A framework for secondary cognitive and motor tasks in dual-task gait testing in people with mild cognitive impairment. BMC Geriatr. 2018 Sep 3;18(1):202. doi: 10.1186/s12877-018-0894-0.

  PMID: 30176796 BACKGROUND

• Jahn, T. & Heßler, J. B. (2017). Handanweisung Kognitive Funktionen Demenz (Kurzbezeichung CFD). Mödling: Schufried GmbH

  BACKGROUND

• Juraszovich, B.; Sax, G.; Rappold, E.; Pfabigan, D. & Stewig, F. (Hg). (2015). Demenzstrategie Gut Leben mit Demenz. Wien: Bundesministerium für Gesundheit und Sozialministerium; 2015.

  BACKGROUND

• Kivipelto M, Solomon A, Ahtiluoto S, Ngandu T, Lehtisalo J, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Nissinen A, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER): study design and progress. Alzheimers Dement. 2013 Nov;9(6):657-65. doi: 10.1016/j.jalz.2012.09.012. Epub 2013 Jan 17.

  PMID: 23332672 BACKGROUND

• Lin KC, Wu YF, Chen IC, Tsai PL, Wu CY, Chen CL. Dual-task performance involving hand dexterity and cognitive tasks and daily functioning in people with schizophrenia: a pilot study. Am J Occup Ther. 2015 May-Jun;69(3):6903250020p1-7. doi: 10.5014/ajot.2014.014738.

  PMID: 25871598 BACKGROUND

• Luttenberger K, Reppermund S, Schmiedeberg-Sohn A, Book S, Graessel E. Validation of the Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment (ETAM). BMC Geriatr. 2016 May 26;16:111. doi: 10.1186/s12877-016-0271-9.

  PMID: 27229937 BACKGROUND

• Lourida I, Soni M, Thompson-Coon J, Purandare N, Lang IA, Ukoumunne OC, Llewellyn DJ. Mediterranean diet, cognitive function, and dementia: a systematic review. Epidemiology. 2013 Jul;24(4):479-89. doi: 10.1097/EDE.0b013e3182944410.

  PMID: 23680940 BACKGROUND

• Yahiaoui-Doktor M, Luck T, Riedel-Heller SG, Loeffler M, Wirkner K, Engel C. Olfactory function is associated with cognitive performance: results from the population-based LIFE-Adult-Study. Alzheimers Res Ther. 2019 May 10;11(1):43. doi: 10.1186/s13195-019-0494-z.

  PMID: 31077241 BACKGROUND

Related Links

• OECD. Health at a Glance 2017: OECD Indicators, OECD Publishing, 2017, Paris.

MeSH Terms

Conditions

Cognitive Dysfunction; Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Study Officials

• Wolfgang Staubmann, BSc MSc

  University of Applied Sciences, FH JOANNEUM

  STUDY DIRECTOR

Central Study Contacts

Monica Christova, PhD

CONTACT

+433165453; monica.christova@fh-joanneum.at

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 18, 2019
• Study Start: January 7, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)