The Impact of a Heart Failure Review on Self-Care Knowledge, Adherence and Clinical Outcomes

January 29, 2019 updated by: Katie Packard, Creighton University
This study is assessing the effects of a new heart failure self-care education program in the Nebraska Heart Institute Heart Improvement Clinic. The new education program will consist of an initial intensive self-care education session with the Principal Investigator or her nurse practitioner. Topics to be discussed include medications, sodium and fluid consumption, alcohol restriction, exercise, preventive behaviors, and monitoring of signs and symptoms. As recommended in the ACCF/AHA guidelines, this education will be repeated on an annual basis as studies have shown that the impact of HF education is not always durable and must be a continual process. This study will assess the impact of this review on their medication knowledge, disease state knowledge, quality of life, disease state progression and clinical outcomes such as ejection fraction and number of hospitalizations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an observational study as all patients in the heart failure clinic, regardless of whether or not they will choose to be in the study, will receive heart failure self-care education from now on.

Study Type

Observational

Enrollment (Actual)

57

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
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart Institute
      • Omaha, Nebraska, United States, 68178
        • Creighton University

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adults ages 19 and older with heart failure

Description

Inclusion Criteria:

  • Males and females ages 19 and older
  • Able to speak, read and understand English and able to understand and provide informed consent
  • Diagnosis of cardiomyopathy and/or HF, preserved or reduced ejection fraction

Exclusion Criteria:

  • Patients not-responsible for self-care.
  • Inability to provide written informed consent.
  • Co-morbid condition with an expected survival of less than six 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
Intervention / Treatment
self-care education
All patients in the study will receive self-care education
Behavioral: heart failure self-care education
It is defined as a naturalistic decision-making process that patients use in the choice of behaviors that maintain physiological stability (symptom monitoring and treatment adherence) and the response to symptoms when they occur (Riegel 2004). This includes following advice regarding medications, sodium and water consumption, alcohol restriction, exercise, preventive behaviors, and monitoring of signs and symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of hospitalizations
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ejection fraction
Time Frame: 12 months
12 months
change in heart failure medication knowledge
Time Frame: 12 months
Adapted from the Atlanta Heart Failure Knowledge Test V2 (AHFKT-VT) (Miller Reilly C 2009) Grading: 1 point for correct answer, 0 points for incorrect or skipped Total points and divide by 6 for percentage score
12 months

Collaborators and Investigators

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

Sponsor

Creighton University

Collaborators

CHI Nebraska Heart

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, 2015

Primary Completion (Actual)

January 22, 2019

Study Completion (Actual)

January 22, 2019

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 742726-1

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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