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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01064765
First Posted: February 8, 2010
Last Update Posted: September 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sigma-Tau Research, Inc.
Information provided by (Responsible Party):
University of Chicago
  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 ]

Secondary Outcome Measures:
  • Duration of hospitalization(s) [ Time Frame: 90 days after enrollment ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01064765     History of Changes
Other Study ID Numbers: 16233A
First Submitted: February 3, 2010
First Posted: February 8, 2010
Last Update Posted: September 5, 2013
Last Verified: September 2013

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases