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NCT Number: NCT03175302

PREsurgical Cognitive Evaluation Via Digital clockfacEdrawing

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.

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Key information

Conditions

Cognitive Dysfunction Cognition Disorders Mental Disorders Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UF Health

Gainesville, Florida, 32610, United States

Location status: Recruiting

Location contact

Catherine Price, Ph.D.

CONTACT

[email protected]

352-494-6999

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

digital cognitive testing

Behavioral

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

Primary outcomes

  1. Control and pre-surgery differences between digital behaviors

    Time frame: up to one year

    Measure range of digital outcome differences

Secondary outcomes

  1. Predictive validity of digital behaviors on outcome

    Time frame: up to 1 year

    Digital tools will predict clinician reported events

  2. Change over time in digital behavior between groups

    Time frame: up to 6-weeks

    Surgery group and control group differences from baseline to 6-weeks

  3. Change over time in digital behavior between groups

    Time frame: up to 3-months

    Surgery group and control group differences from baseline to 3-months

  4. Change over time in digital behavior between groups

    Time frame: up to one year

    Surgery group and control group differences from baseline to one year

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Gunnett, RN

CONTACT

[email protected]

352-273-8911

Catherine Price, Ph.D.

CONTACT

[email protected]

352-494-6999

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute on Aging (NIA)

Registry information

Acronym: PRECEDE

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2017
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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