PREsurgical Cognitive Evaluation Via Digital clockfacEdrawing

Cognitive Dysfunction Clinical Trial

— PRECEDE  

Official title:

PREsurgical Cognitive Evaluation Via Digital clockfacEdrawing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03175302
• Other study ID #: IRB201700747-N
• Secondary ID: R01AG055337OCR18
• Status: Recruiting
• Start date: June 28, 2018
• Est. completion date: May 31, 2024

Study information

• Verified date: January 2024
• Source: University of Florida
• Contact: Catherine Price, Ph.D.
• Phone: 352-494-6999
• Email: cep23[@]phhp.ufl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25240
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction

Intervention

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

Locations

Country	Name	City	State
United States	UF Health	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	National Center for Advancing Translational Sciences (NCATS), National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Control and pre-surgery differences between digital behaviors	Measure range of digital outcome differences	up to one year
Secondary	Predictive validity of digital behaviors on outcome	Digital tools will predict clinician reported events	up to 1 year
Secondary	Change over time in digital behavior between groups	Surgery group and control group differences from baseline to 6-weeks	up to 6-weeks
Secondary	Change over time in digital behavior between groups	Surgery group and control group differences from baseline to 3-months	up to 3-months
Secondary	Change over time in digital behavior between groups	Surgery group and control group differences from baseline to one year	up to one year