Linus Health CDS Retrospective Validation Study

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05900310
• Other study ID #: CDSV-001
• Status: Not yet recruiting
• Start date: June 2023
• Est. completion date: August 2023

Study information

• Verified date: June 2023
• Source: Linus Health, Inc.
• Contact: Ali Jannati, MD, PhD
• Phone: 6174173002
• Email: ajannati[@]linus.health
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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"

Related Conditions & MeSH terms

• Cognitive Impairment
• Dementia
• Motor Disorders

Intervention

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).

Locations

Country	Name	City	State
United States	Linus Health, Inc.	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Linus Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median rating of each CDS recommendation	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.	2-3 weeks
Secondary	Intraclass correlation coefficient (ICC) of each rating	ICC of each rating of clinical appropriateness to evaluate the inter-rater variability.	2-3 weeks