Cognitive Impairment, Dementia, Motor Disorders
Conditions
Brief summary
This study is a retrospective validation study of deidentified Clinical Decision Support (CDS) recommendations generated by the Linus Health Core Cognitive Evaluation (CCE) for patients who have completed the CCE. Site investigators consist of clinical experts including neurologists and geriatricians in the U.S. After signing the study agreements, the experts will receive batches of anonymized CCE outputs of patients and will rate the appropriateness of each CDS recommendation for each patient based on their review of the CCE results and their clinical judgment and expertise. The experts will also rate the clinical appropriateness of various parts of CDS pathways that form the LH CDS decision tree.
Interventions
DIAGNOSTIC_TESTCore Cognitive Evaluation (CCE)
The Linus Health Core Cognitive Evaluation (CCE) is an easy-to-use but powerful tool to augment and facilitate cognitive health assessment during a patient's visit to their PCP. As a digital assessment solution, the CCE combines objective insights into cognitive ability with patient-reported insights to detect early signs of cognitive impairment and reveal specific modifiable risk factors earlier than the existing status quo assessments. The CCE is an FDA-listed Class II 510k exempt software as a medical device. The CCE has two components: The Digital Clock and Recall (DCR™) test and the Life and Health Questionnaire (LHQ).
Sponsors
Linus Health, Inc.
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 55 and above * Has already completed the Linus Health CCE
Exclusion criteria
* Incomplete CCEs * CCEs that are flagged as Requires clinician review
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median rating of each CDS recommendation | 2-3 weeks | Rating of clinical appropriateness on the scale of 1 (extremely inappropriate) to 9 (extremely appropriate) for each set of CDS recommendations generated by the Linus Health CCE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraclass correlation coefficient (ICC) of each rating | 2-3 weeks | ICC of each rating of clinical appropriateness to evaluate the inter-rater variability. |
Countries
United States
Contacts
Primary ContactAli Jannati, MD, PhD
Backup ContactWilliam I Morrow, B.S.
Outcome results
None listed