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

September 4, 2013 updated by: University of Chicago
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

72

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

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
Heart failure
Outpatients with heart failure, age 75 or less, left ventricular ejection fraction 40% or less, english speaking with no known dementia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-management of heart failure as measured by the Self-Care in Heart Failure Index
Time Frame: at time of enrollment
at time of enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of hospitalization(s)
Time Frame: 90 days after enrollment
90 days after enrollment

Collaborators and Investigators

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

Sponsor

University of Chicago

Collaborators

Sigma-Tau Research, Inc.

Investigators

  • Principal Investigator: Savitri E. Fedson, MD, University of Chicago

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

September 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

February 3, 2010

First Submitted That Met QC Criteria

February 5, 2010

First Posted (Estimate)

February 8, 2010

Study Record Updates

Last Update Posted (Estimate)

September 5, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16233A

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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