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

NCT ID: NCT02415751

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 57 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2019-01-22

Brief Summary

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.

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

self-care education

All patients in the study will receive self-care education

heart failure self-care education

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHI Nebraska Heart

UNKNOWN

Sponsor Role: collaborator

Creighton University

OTHER

Sponsor Role: lead

Responsible Party

Katie Packard

Co-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katie Packard, PharmD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

Nebraska Heart Institute

Lincoln, Nebraska, United States

Creighton University

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

742726-1

Identifier Type: -

Identifier Source: org_study_id