Cognitive Function in Adults With Cardiac Disease (TimePoints)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University Hospital Case Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01043315
First received: January 5, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.

Condition
Cognitive Impairment
Cardiology
Cardiac Disease
Hospitalization

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cognitive Function in Adults With Cardiac Disease

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Estimated Enrollment: 60
Study Start Date: July 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hospitalized Cardiac Patient
Adults admitted to Coronary intensive unit being treated for acute cardiovascular conditions

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043315

Contacts
Contact: Denise Lin-DeShetler, MPH, MA 216-368-3839 denise.lin@case.edu

Locations
United States, Ohio
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Richard Josephson, MS, MD    216-844-2775    Richard.Josephson@UHhospitals.org   
Principal Investigator: Richard Josephson, MS, MD         
Principal Investigator: Mary Dolansky, RN, PhD         
Sponsors and Collaborators
University Hospital Case Medical Center
Investigators
Principal Investigator: Richard Josephson, MS, MD University Hospital Case Medical Center
  More Information

No publications provided

Responsible Party: Richard Josephson, MS, MD, University Hospitals Case Medical Center
ClinicalTrials.gov Identifier: NCT01043315     History of Changes
Other Study ID Numbers: 05-09-25
Study First Received: January 5, 2010
Last Updated: January 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
Cognitive Function
Cognitive Impairment
Hospitalization
Cardiac Disease

Additional relevant MeSH terms:
Heart Diseases
Cognition Disorders
Cardiovascular Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014