NCT03175302

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,240

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jun 2018May 2027

First Submitted

Initial submission to the registry

June 1, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 28, 2018

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

8.9 years

First QC Date

June 1, 2017

Last Update Submit

July 28, 2025

Conditions

Cognitive Dysfunction

Keywords

cognitive processesperioperative cognitionneurocognitive impairment

Outcome Measures

Primary Outcomes (1)

  • Control and pre-surgery differences between digital behaviors

    Measure range of digital outcome differences

    up to one year

Secondary Outcomes (4)

  • Predictive validity of digital behaviors on outcome

    up to 1 year

  • Change over time in digital behavior between groups

    up to 6-weeks

  • Change over time in digital behavior between groups

    up to 3-months

  • Change over time in digital behavior between groups

    up to one year

Study Arms (2)

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.

Behavioral: digital cognitive testing

Control

Non-surgery matched peers with the same testing.

Behavioral: digital cognitive testing

Interventions

digital cognitive testingBEHAVIORAL

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

ControlSurgical group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients \>/= 65 years of age scheduled for screening within the UF Health Preoperative clinic

You may qualify if:

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

You may not qualify if:

  • \< 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 37149670DERIVED

  • 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.

    PMID: 35568709DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Catherine Price, Ph.D.

    University of Florida

    PRINCIPAL INVESTIGATOR

  • Patrick Tighe, MD, MS

    University of Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Price, Ph.D.

CONTACT

352-494-6999cep23@phhp.ufl.edu

Amy Gunnett, RN

CONTACT

352-273-8911agunnett@anest.ufl.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2017

First Posted

June 5, 2017

Study Start

June 28, 2018

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)