NCT05900310

Linus Health CDS Retrospective Validation Study

Retrospective Validation Study of Clinical Decision Support (CDS) Recommendations in the Linus Health Core Cognitive Evaluation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Linus Health, Inc. · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cognitive Impairment
• Motor Disorders
• Dementia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Core 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).

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-07-01
• Completion: 2023-08-01
• First posted: 2023-06-12
• Last updated: 2023-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study