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

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: heart failure self-care education

• Registration Number: NCT02415751
• Lead Sponsor: Creighton University

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.

Study Timeline

• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-09
• Study First Posted: 2015-04-14
• Study Start: 2015-06
• Status Verified: 2019-01
• Primary Completion: 2019-01-22
• Study Completion: 2019-01-22
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
self-care education	heart failure self-care education	All patients in the study will receive self-care education

Primary Outcome Measures

Name	Time	Method
number of hospitalizations	12 months

Secondary Outcome Measures

Name	Time	Method
ejection fraction	12 months
change in heart failure medication knowledge	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

Trial Locations

Locations (2)

Nebraska Heart Institute; 🇺🇸 Lincoln, Nebraska, United States

Creighton University; 🇺🇸 Omaha, Nebraska, United States