The Impact of a Heart Failure Review on Self-Care Knowledge, Adherence and Clinical Outcomes
1 other identifier
observational
57
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2015
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2015
CompletedFirst Posted
Study publicly available on registry
April 14, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2019
CompletedJanuary 30, 2019
January 1, 2019
3.6 years
April 7, 2015
January 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
number of hospitalizations
12 months
Secondary Outcomes (2)
ejection fraction
12 months
change in heart failure medication knowledge
12 months
Study Arms (1)
self-care education
All patients in the study will receive self-care education
Interventions
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.
Eligibility Criteria
adults ages 19 and older with heart failure
You may qualify if:
- 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
You may not qualify if:
- Patients not-responsible for self-care.
- Inability to provide written informed consent.
- Co-morbid condition with an expected survival of less than six months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Creighton Universitylead
- CHI Nebraska Heartcollaborator
Study Sites (2)
Nebraska Heart Institute
Lincoln, Nebraska, 68526, United States
Creighton University
Omaha, Nebraska, 68178, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katie Packard, PharmD
Creighton University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-Investigator
Study Record Dates
First Submitted
April 7, 2015
First Posted
April 14, 2015
Study Start
June 1, 2015
Primary Completion
January 22, 2019
Study Completion
January 22, 2019
Last Updated
January 30, 2019
Record last verified: 2019-01