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ACT-HF: Attention, Cognition and Self-Management in Heart Failure

This study has been completed.
Sponsor:
Collaborator:
Sigma-Tau Research, Inc.
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01064765
First received: February 3, 2010
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

This study is designed to determine if a relationship exists between problems with memory, attention, learning, insight and executive function and self management in heart failure.


Condition
Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: ACT-HF: Attention, Cognition and Self-Management in Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Self-management of heart failure as measured by the Self-Care in Heart Failure Index [ Time Frame: at time of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of hospitalization(s) [ Time Frame: 90 days after enrollment ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: September 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Heart failure
Outpatients with heart failure, age 75 or less, left ventricular ejection fraction 40% or less, english speaking with no known dementia

Detailed Description:

Eligible participants are those 75 years of age or less, with left ventricular ejection fractions of 40% or less, english speaking and no known cognitive deficits. Participants will be administered the Repeatable Battery for the Assessment of Neuropsychological Status and the Controlled Oral Word Association test at the study visit. They will also be asked to complete the Self-Care in Heart Failure Index and the Anosognosia Questionnaire for Dementia at their convenience and mail back to investigator. Participants will be contacted in 90 days to determine if they have been hospitalized, and if so, for how many days.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients with history of heart failure 6 months or more meeting inclusion criteria recruited from outpatient clinic who receiving routine care for their heart failure

Criteria

Inclusion Criteria:

  • 75 years of age or less
  • ejection fraction 40% or less
  • heart failure 6 months or more
  • English speaking
  • no known dementia
  • no active substance abuse
  • presence of caregiver/support

Exclusion Criteria:

  • neurologic disorders potentially causing cognitive dysfunction
  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: NCT01064765

Locations
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Sigma-Tau Research, Inc.
Investigators
Principal Investigator: Savitri E. Fedson, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01064765     History of Changes
Other Study ID Numbers: 16233A
Study First Received: February 3, 2010
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Heart failure
Self management
cognitive dysfunction
Self management of heart failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014