Cognitive Function in Adults With Cardiac Disease (TimePoints)

April 14, 2022 updated by: Richard Josephson, MS MD, University Hospitals Cleveland Medical Center

The purpose of this study is to identify cardiac patients' degree of unappreciated mild impairment in cognitive function patterns of cognitive function, and influencing factors related to cognitive functioning during hospitalization. The results from the study will contribute to tailoring the delivery of patient education to optimize patient understanding of information in future clinical practice.

It is hypothesized that the study will demonstrate the following:

  1. The degree of cognitive function for patients hospitalized in a CICU will be below the scores for normal functioning adults.
  2. Patients with acute cardiovascular conditions will score differently in cognitive functioning at various times throughout their hospitalization.
  3. Relationships between cognitive function and following variables:

    • Patients with greater sleep deprivation or fatigue will exhibit lower cognitive functioning.
    • Patients with greater hunger will exhibit lower cognitive functioning.
    • Patients who are experiencing greater anxiety will exhibit lower cognitive functioning.
    • Patients who are experiencing depression will exhibit lower cognitive functioning.
    • Patients who have undergone or will undergo shortly treatment or procedures will exhibit lower cognitive functioning.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients hospitalized in the University Hospitals' (Cleveland, OH) coronary intensive unit (CICU) being treated for acute cardiovascular conditions

Description

Inclusion Criteria:

  • Admission to the Cardiac Intensive Care Unite for acute cardiological issues during time of enrollment.
  • Patients with NYHA class I, II, III, and IV.
  • 18 years or older and must be awake and conversant at time of enrollment.

Exclusion Criteria:

  • History of neurological disorder or injury (e.g., Alzheimer's Disease, dementia, stroke, seizures).
  • Moderate or severe head injury (defined as > 24 hours loss of consciousness)
  • Past or current history of severe psychiatric illness. Specifically, psychotic disorders (e.g., schizophrenia) and bipolar disorder. Potential participants will not be excluded on the basis of managed depression or anxiety disorder. These conditions are common in cardiac patients and their exclusion may limit the generalizability of findings.
  • 5 years past or current history of alcohol or drug abuse (defined by DSM-IV criteria).
  • History of learning disorder or developmental disability (defined by DSM-IV criteria).
  • Renal failure requiring dialysis.
  • History of sleep apnea (defined through previous sleep studies).
  • Severely ill individuals, including those who are sedated, on a ventilator, exhibiting acute hemodynamic changes, and/or those deemed inappropriate by patient's physician to participate in study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hospitalized Cardiac Patient
Adults admitted to Coronary intensive unit being treated for acute cardiovascular conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cognitive Function as measured by Modified Mini Mental Status (3MS) Examination
Time Frame: Up to 3 hours prior to discharge
Up to 3 hours prior to discharge
Cognitive Function as measured by Rey Auditory Verbal Learning
Time Frame: Up to 3 hours prior to discharge
Up to 3 hours prior to discharge
Cognitive Function as measured by Trails testing
Time Frame: Up to 3 hours prior to discharge
Up to 3 hours prior to discharge
Cognitive Function as measured by Digit Span Backwards
Time Frame: Up to 3 hours prior to discharge
Up to 3 hours prior to discharge
Cognitive Function as measured by Rey Auditory Verbal Learning Long Delay
Time Frame: Up to 3 hours prior to discharge
Up to 3 hours prior to discharge
Cognitive Function as measured by Rey Auditory Verbal Learning Long Delay and Recognition
Time Frame: Up to 3 hours prior to discharge
Up to 3 hours prior to discharge
Cognitive Function as measured by Frontal Assessment Battery
Time Frame: Up to 3 hours prior to discharge
Up to 3 hours prior to discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Richard Josephson, MS, MD, University Hospitals Cleveland Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimate)

January 6, 2010

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

April 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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