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

April 6, 2016 updated by: Tony Vehovec, Kent State University

Cognitive Impairment and Self-management in Adults With Heart Failure

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?

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

372

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
    • Ohio
      • Akron, Ohio, United States, 44309
        • Summa Health System

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

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

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
left systolic heart failure (EF </= 40%)

Collaborators and Investigators

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

Sponsor

Kent State University

Collaborators

University Hospitals Cleveland Medical Center
Case Western Reserve University
Summa Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2010

Primary Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

October 26, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (Estimate)

October 28, 2011

Study Record Updates

Last Update Posted (Estimate)

April 7, 2016

Last Update Submitted That Met QC Criteria

April 6, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10217650 (Other Grant/Funding Number: NHLBI)

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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