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Linus Health CDS Retrospective Validation Study

Sponsor
Linus Health, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05900310
Collaborator
(none)
40
Enrollment
1
Location
2
Anticipated Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Core Cognitive Evaluation (CCE)

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Retrospective Validation Study of Clinical Decision Support (CDS) Recommendations in the Linus Health Core Cognitive Evaluation
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Intraclass correlation coefficient (ICC) of each rating [2-3 weeks]

    ICC of each rating of clinical appropriateness to evaluate the inter-rater variability.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts 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"

Contacts and Locations

Locations

Site City State Country Postal Code
1 Linus Health, Inc. Boston Massachusetts United States 02210

Sponsors and Collaborators

  • Linus Health, Inc.

Investigators

  • Principal Investigator: Ali Jannati, MD, PhD, Linus Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Linus Health, Inc.
ClinicalTrials.gov Identifier:
NCT05900310
Other Study ID Numbers:
  • CDSV-001
First Posted:
Jun 12, 2023
Last Update Posted:
Jun 12, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Motor Disorders

Study Results

No Results Posted as of Jun 12, 2023