PREsurgical Cognitive Evaluation Via Digital clockfacEdrawing

Recruiting

• Conditions: Cognitive Dysfunction
• Interventions: Behavioral: digital cognitive testing

• Registration Number: NCT03175302
• Lead Sponsor: University of Florida

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-05
• Study Start: 2018-06-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25240

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)

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	digital cognitive testing	Non-surgery matched peers with the same testing.
Surgical group	digital cognitive testing	Baseline preoperative digital cognitive testing performance in adults to predict frequency and severity of clinician reported outcomes within the first three months post-surgery.

Primary Outcome Measures

Name	Time	Method
Control and pre-surgery differences between digital behaviors	up to one year	Measure range of digital outcome differences

Secondary Outcome Measures

Name	Time	Method
Predictive validity of digital behaviors on outcome	up to 1 year	Digital tools will predict clinician reported events
Change over time in digital behavior between groups	up to one year	Surgery group and control group differences from baseline to one year

Trial Locations

Locations (1)

UF Health; 🇺🇸 Gainesville, Florida, United States