Linus Health CDS Retrospective Validation Study

NCT ID: NCT05900310

Last Updated: 2023-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-30

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cognitive Impairment Motor Disorders Dementia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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"
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Linus Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ali Jannati, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Linus Health

Locations

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Linus Health, Inc.

Boston, Massachusetts, United States

Site Status

Countries

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United States

Central Contacts

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Ali Jannati, MD, PhD

Role: CONTACT

6174173002

William I Morrow, B.S.

Role: CONTACT

Facility Contacts

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Ali Jannati, MD, PhD

Role: primary

617-417-3002

William I Morrow

Role: backup

Other Identifiers

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CDSV-001

Identifier Type: -

Identifier Source: org_study_id

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