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Self-management and Cognitive Function in Adults With Heart Failure (Heart ABC)

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.
 
ClinicalTrials.gov Identifier: NCT01461629
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : April 7, 2016
Sponsor:
Collaborators:
Summa Health System
Case Western Reserve University
University Hospitals Cleveland Medical Center
Information provided by (Responsible Party):
Tony Vehovec, Kent State University

Study Description
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Brief Summary:

The purpose of this study is to assess the relationship between cognitive impairment, patient self-management, health, and health service use in adults with heart failure (NYHA Class 2 and 3). The research questions are:

  1. How is cognitive impairment (memory, attention, global and executive function) related to various aspects of impaired self-management (knowledge of adherence, adherence to sodium restriction and medications, symptom monitoring of weight changes, and decision and action to seek care)?
  2. How are these relationships altered when adjusting for medical, demographic, and psychosocial factors?
  3. What are the relationships among degree of cognitive impairment, quality self-management, health status, and health service use?

Condition or disease
Cognitive Impairment Cardiac Disease Heart Failure

Study Design
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Study Type : Observational
Actual Enrollment : 372 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cognitive Impairment and Self-management in Adults With Heart Failure
Study Start Date : June 2010
Actual Primary Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort
heart failure
left systolic heart failure (EF </= 40%)


Outcome Measures
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Biospecimen Retention:   Samples Without DNA
Urinary sodium

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
50-85 years of age, documented diagnosis of systolic heart failure (EF </= 35%) at least 12 months prior to enrollment
Criteria

Inclusion Criteria:

  • documented systolic heart failure
  • NYHA class II, III of at least 6 months duration
  • 50-85 years of age
  • has a telephone (land line) or be willing to allow a telephone installed for duration of study

Exclusion Criteria:

  • history of neurological disorder or injury
  • moderate or severe head injury
  • past or current history of severe psychiatric illness; specifically, psychotic disorders and bipolar disorder
  • 5 year past or current history of alcohol or drug abuse
  • history of learning disorder or developmental disability
  • renal failure requiring dialysis
  • history of sleep apnea
  • current home telemonitoring program to assist w/ HF self-management
  • cardiac surgery < 3 months
Contacts and Locations
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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): NCT01461629


Locations
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United States, Ohio
Summa Health System
Akron, Ohio, United States, 44309
Sponsors and Collaborators
Kent State University
Summa Health System
Case Western Reserve University
University Hospitals Cleveland Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tony Vehovec, Associate Professor, Kent State University
ClinicalTrials.gov Identifier: NCT01461629    
Other Study ID Numbers: 10217650
10217650 ( Other Grant/Funding Number: NHLBI )
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016
Keywords provided by Tony Vehovec, Kent State University:
cognitive impairment
cognitive function
hospitalization
 self-management
cardiac disease
heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cognitive Dysfunction
Cardiovascular Diseases
 Cognition Disorders
Neurocognitive Disorders
Mental Disorders