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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415751
• Other study ID #: 742726-1
• Status: Completed
• Start date: June 2015
• Est. completion date: January 22, 2019

Study information

• Verified date: January 2019
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 22, 2019
• Est. primary completion date: January 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Creighton University	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	CHI Nebraska Heart

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of hospitalizations		12 months
Secondary	ejection fraction		12 months
Secondary	change in heart failure medication knowledge	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