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Protocol for the conceptualization and evaluation of a screening-tool for fitness-to-drive assessment in elders with cognitive impairment

Protocol for the conceptualization and evaluation of a screening-tool for fitness-to-drive assessment in elders with cognitive impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00023549
Enrollment
80
Registered
2020-11-26
Start date
2020-12-14
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Healthy volunteers F06.7

Interventions

Group 1: Assessment of psychopathology and extensive neuropsychological examination of cognitively impaired elders over 50 years (experimental group) by means of standardized test procedures. In order
Mini-Symptom-Checklist, Mini-SCL
Perceived Deficits Questionnaire, PDQ). The neuropsychological assessment comprises the test battery Cognitive Functions Dementia (CFD), the Line Orientation Test (LAT, abbreviation based on the Germa

Sponsors

Inn-Salzach-Klinikum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 100 Years

Inclusion criteria

Inclusion criteria: Age = 50 years; valid driver license; constant participation in road traffic; good German language skills; MMSE =18 and <27 for the cognitively impaired patients: 20 patients with organic, including symptomatic disorders (F00-F09), 10 with affective disorders (F30-F39), 10 with schizophrenia, schizotypal or delusional disorders (F20-F29) or neurotic, stress-related and somatoform disorders (F40-F48); MMSE = 27 for the healthy controls

Exclusion criteria

Exclusion criteria: Moderate to severe dementia (MMSE < 18); severe psychiatric, neurological or internistic disease; no current radio- or chemotherapy; visual impairment (visual acuity worse than 60%; visual field <140°, double vision, hemi-neglect)

Design outcomes

Primary

MeasureTime frame
The primary outcomes comprise the results of the neuropsychological assessment in attention (intrinsic alertness, divided attention, processing speed), visuospatial abilities (visuoconstruction, visual orientation) and executive functions (working memory, cognitive flexibility). The test-set Cognitive Functions Dementia (CFD), the Judgement-of-Line-Orientation-Test (JLO) and Clock-Drawing-Test (CDT) are applied. Furthermore the performance in the on-road assessment can be measured by means of an overall rating on an 11-point rating scale or on a more detailed level on the basis of tactical errors, operational errors or cognitively based tactical errors.

Secondary

MeasureTime frame
Secondary outcome variables are performances in neuropsychological domains such as expressive speech/language (lexical verbal fluency, semantic verbal fluency, object naming), and verbal long term memory (learning ability, short-term delayed recall, long-term delayed recall, recognition) acquired by the test-set Cognitive Functions Dementia (CFD). Anamnestic data – sociodemographic (age, gender, level of education, occupation etc.), clinical (record of diseases, medication etc.) and traffic-specific (years of traffic participation, crashes, fees etc.) – will be analyzed with respect to their influence on the prediction of driving behavior. Standardized questionnaires, interviews and Rating scales (Mini-Mental-State-Examination, MMSE; Mini-Symptom-Checklist, Mini-SCL; Perceived Deficits Questionnaire, PDQ) will be used.

Countries

Germany

Contacts

Public ContactLeonhard Zellner

Inn-Salzach-Klinikum, Abt. Neuropsychologie

Leonhard.Zellner@kbo.de0049 8071 71360

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 14, 2026