F06.7
Conditions
Interventions
Group 1: Individuals with suspected MCI use the neotivCare app, optionally supported by the Mili chatbot. Regardless of the result, all are referred to a memory clinic.
Sponsors
Deutsches Zentrum für Neurodegenerative Erkrankungen e.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Informed consent • Age 60 – 80 years • Individuals who require medical advice due to self-perceived or family-perceived or suspected memory problems • Individuals deemed suitable for thorough diagnostics by their treating physician and who have answered both questions of the SCD-Q (Subjective Cognitive Decline Questionnaire) with "Yes" • Sufficient knowledge of the German language to participate in all elements of the study
Exclusion criteria
Exclusion criteria: • Causes of cognitive impairment not related to a suspected neurodegenerative process • Suspected manifest dementia, defined as a clinical suspicion of dementia by a physician based on standardized diagnostic criteria • Inability to regularly use a smartphone • Current psychiatric disorders • Known current neurological diseases of the brain • Visual and/or hearing impairments that interfere with the conduct of the examinations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of appropriate referrals by office-based specialist physicians after presentation of the neotivCare app report, compared with S3 guideline–based assessments in memory clinics. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional endpoints to help assess improvements in care include: 1. Increase in the proportion of MCI due to Alzheimer’s disease (estimated based on reference tests in combination with pTau217) among referrals from the group using the neotivCare app compared to referrals from standard care. 2. Insights from additional questionnaires, such as: • Perceived value and satisfaction with neotivCare compared to standard referral and the MoCA test. • Referral practices reported by healthcare professionals, along with reasons and barriers for delayed MCI diagnosis. • Feedback from healthcare professionals on how they experienced the new approach: How they assess the impact of digital remote diagnosis of MCI. How many patients they expect to assess in the future using neotivCare or MoCA. How much time they think can be saved per patient. • Feedback from patients on using the app: How easy it is to use, concerns about self-assessment, and how it affects their relationship with their healthcare provider. Whether it supports shared decision-making with their provider. • Patient outcomes related to quality of life, disease burden, and mental well-being. • Estimated number of correct referrals resulting from the group using the neotivCare app, compared to the reference test and MoCA. • Estimated cost savings based on reducing unnecessary or incorrect referrals. 3. Feasibility of using automated, speech-based cognitive assessments with speech biomarkers (developed by ki:elements) during specialized memory clinic appointments. | — |
Countries
Germany
Outcome results
None listed