PREsurgical Cognitive Evaluation Via Digital clockfacEdrawing

NCT ID: NCT03175302

Last Updated: 2025-07-31

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

RECRUITING

Total Enrollment

25240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-28

Study Completion Date

2027-05-31

Brief Summary

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This study leverages a modernized digital version of a well-known cognitive screening tool to examine pre and post operative cognitive function after surgery in adults age 65 years or more. Machine learning algorithms will be applied to the hospital wide standard of care cognitive metric to identify risk for post-operative cognitive complications.

Detailed Description

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This proposal innovatively leverages a brief but informative digital test with machine learning to examine the subtlety of pre-surgery cognition within an extremely large number of older individuals screened preoperatively within an academic tertiary medical center. It also incorporates a unique group of well characterized non-surgery peers for demographic matching to assist with normal versus abnormal machine learning analyses.

Conditions

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Cognitive Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Surgical group

Baseline preoperative digital cognitive testing performance in adults to predict frequency and severity of clinician reported outcomes within the first three months post-surgery.

digital cognitive testing

Intervention Type BEHAVIORAL

The digital testing is hypothesized to identify latent features for differentiating cognitively impaired presurgical patient subgroups

Control

Non-surgery matched peers with the same testing.

digital cognitive testing

Intervention Type BEHAVIORAL

The digital testing is hypothesized to identify latent features for differentiating cognitively impaired presurgical patient subgroups

Interventions

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digital cognitive testing

The digital testing is hypothesized to identify latent features for differentiating cognitively impaired presurgical patient subgroups

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* \>/= 65 years of age
* screening within the University of Florida (UF) Health Preoperative clinic
* presurgical cognitive screening with the digital Clock Drawing Tool (dCDT)

Exclusion Criteria

* \< 65 years of age
* did not complete screening within the UF Health Preoperative clinic
* did not complete the presurgical cognitive screening with the digital Clock Drawing Tool (dCDT)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine Price, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Patrick Tighe, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Health

Gainesville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Catherine Price, Ph.D.

Role: CONTACT

352-494-6999

Amy Gunnett, RN

Role: CONTACT

352-273-8911

Facility Contacts

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Catherine Price, Ph.D.

Role: primary

352-494-6999

References

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Bandyopadhyay S, Wittmayer J, Libon DJ, Tighe P, Price C, Rashidi P. Explainable semi-supervised deep learning shows that dementia is associated with small, avocado-shaped clocks with irregularly placed hands. Sci Rep. 2023 May 6;13(1):7384. doi: 10.1038/s41598-023-34518-9.

Reference Type DERIVED
PMID: 37149670 (View on PubMed)

Bandyopadhyay S, Dion C, Libon DJ, Price C, Tighe P, Rashidi P. Variational autoencoder provides proof of concept that compressing CDT to extremely low-dimensional space retains its ability of distinguishing dementia. Sci Rep. 2022 May 14;12(1):7992. doi: 10.1038/s41598-022-12024-8.

Reference Type DERIVED
PMID: 35568709 (View on PubMed)

Other Identifiers

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R01AG055337

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OCR18881

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201700747-N

Identifier Type: -

Identifier Source: org_study_id

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