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Linus Health CDS Retrospective Validation Study

NCT05900310 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-06-12

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Linus Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Ali Jannati, MD, PhD · Linus Health

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2023-07-31
Completion
2023-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05900310 on ClinicalTrials.gov