Mild cognitive impairments
Conditions
Interventions
Group 1: Adult patients diagnosed with mild cognitive impairment (MCI) or with cognitive impairment identified in a simplified Level I diagnostic assessment
Group 2: Adults without cognitive impairmen
Sponsors
Univeritätsklinikum Jena
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: In addition to age, the following inclusion criteria apply to patients: Existing diagnosis of mild cognitive impairment or MoCA < 26, capacity to consent, ability and experience in using a mobile device to use the app, ability to understand instructions in German, possession of a mobile device to use the app, no familiarity with the assessments in NeuroNation and no training with the NeuroNation app in the last year. For healthy participants, the following inclusion criteria apply in addition to age: No relevant previous psychiatric/neurological conditions, capacity to consent, ability and experience in using a mobile device to use the app, ability to understand instructions in German, possession of a mobile device to use the app, no familiarity with the assessments in NeuroNation and no training with the NeuroNation app in the last year.
Exclusion criteria
Exclusion criteria: The following exclusion criteria apply to patients and healthy participants: relevant cognitive, motor, sensory, or language deficits that impede participation (e.g. paresis of the dominant arm or hand, severe, non-correctable visual impairments (unable to visually recognise the app content), or severe aphasia that impairs understanding of instructions, pre-existing, known intellectual disability), manifest dementia (medical report/MMST <23), legal guardianship, familiarity with the assessments in NeuroNation, or training with the NeuroNation app in the last year. In addition, individuals will not be included in the group of healthy participants if they indicate in the online recruitment process that they have cognitive impairments. Those who attend on-site testing will also be tested with the MoCA.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psychometric properties of the app-based cognitive screening tool, including (1) construct validity (convergent/divergent validity), (2) diagnostic quality criteria (sensitivity, specificity, PPV, NPV) and (3) normative reference values. Assessment instruments and time points: Screening module of the German adaptation of the Neuropsychological Assessment Battery (S-NAB): - Administered once at Time Point 1 at the respective study centre in 150 patients and 50 healthy participants tested on site. - Purpose: Validation of the app-based cognitive screening tool by comparison with an established reference instrument. App-based cognitive screening tool: - At Time Point 1, the app-based cognitive screening is administered to 150 patients and 25 healthy participants tested on site, as well as to 1000 healthy participants assessed remotely at home (online sample). - Purpose: Validation, norming Hospital Anxiety and Depression Scale – German version (HADS-D): - Administered at Time Point 1 in 150 patients and 50 healthy participants tested on site. - Purpose: Assessment of affective symptoms for evaluating divergent validity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reliability parameters of the app-based cognitive screening tool (internal consistency, retest reliability), user-friendliness of the application (System Usability Scale) and, exploratively, the additional contribution of continuously recorded vital parameters to improving diagnostic accuracy compared to face-to-face testing (Screening module of the German-language adaptation of the Neuropsychological Assessment Battery). Assessment instruments and time points: App-based cognitive screening tool: - At Time Point 2 (four weeks later), all interested participants are invited to repeat the app-based testing. - Purpose: test–retest reliability Cognitive Failures Questionnaire (CFQ): - Administered at Time Point 1 in 150 patients and 50 healthy participants tested on site. - In addition, the CFQ is optionally offered to all online participants and to all participants completing Time Point 2. - Purpose: Assessment of subjective cognitive complaints for exploratory contextualisation System Usability Scale (SUS): - Administered at Time Point 1 in 150 patients and 50 healthy participants tested on site. - Purpose: Evaluation of the usability of the app test Vital parameter monitoring via fitness tracker: - 150 patients and 50 healthy volunteers on site are offered the opportunity to wear a fitness watch for two weeks from measurement point 1. - The device continuously records physiological data such as heart rate, sleep duration, and physical activity. - Purpose: Exploratory analysis of the potential diagnostic added value of physiological markers in improving the detection of cognitive impairment. | — |
Countries
Germany
Contacts
Public ContactKathrin Finke
Gedächtniszentrum der Klinik für Neurologie des Universitätsklinikums Jena
Outcome results
None listed