MedPath

DiGA neotivCare - digital assessment of cognitive status to identify and monitor cognitive impairments

Phase 4
Conditions
F06.7
Mild cognitive disorder
Registration Number
DRKS00026151
Lead Sponsor
neotiv GmbH
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
180
Inclusion Criteria

patients age 60-80
- s4elf report or suspected cognitive impairments
- ICD-codes F00*, F01*F02*, F06
- mini mental state exam >25
- smartphone available and competency

Exclusion Criteria

- unsable to use a smartphone
- no remote mobiel access
- severe visual or sensual impairments
- other neurological diseases that hinder the use of a phone
- anosognosia

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
test anxiety will be measured using the Test nxiety inventory (TAI-G) in its german version by Hosdap (1991) revised by Schwarzer& Jerusalem (1999).<br>general anxiety will be measured using the Generalized Anxiety Disorder (GAD-7) and the physical health questionnaire (PHQ-D).<br>Patient sovereignity will be measured using a newly developed questionnaire that was validated in a pilot study.<br>
Secondary Outcome Measures
NameTimeMethod
Secondary outcomes regarding procedures in diagnosis will be assessed using a generic questionnaire and data from physician´s patient records.
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