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Completed

NCT Number: NCT02415751

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nebraska Heart Institute, Lincoln, Nebraska, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

heart failure self-care education

Behavioral

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.

Primary outcomes

  1. number of hospitalizations

    Time frame: 12 months

Secondary outcomes

  1. ejection fraction

    Time frame: 12 months

  2. 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

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Collaborators

  • CHI Nebraska Heart

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 14, 2015
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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