- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07280208
Teach-Back Discharge Education to Improve Self-Care and Reduce 30-Day Readmissions in Heart Failure Patients
Impact of Discharge Teach-Back Education on Heart Failure Patients' Knowledge/Self-Care Behaviors and 30-Day Readmissions
Study Overview
Status
Intervention / Treatment
Detailed Description
Heart failure is a chronic and progressive condition affecting millions of adults in the United States. Despite advances in treatment, nearly one in four patients are readmitted to the hospital within 30 days of discharge, often due to poor understanding of discharge instructions and inadequate self-care. These readmissions contribute to worse health outcomes and increased healthcare costs.
This study evaluated the effectiveness of a structured discharge education intervention using the teach-back method. The teach-back method is a communication technique in which patients are asked to repeat discharge instructions in their own words. This approach helps confirm understanding, reinforce learning, and promote active engagement in self-care.
The study used a quasi-experimental, pre-test/post-test design to assess changes in patients' knowledge and self-care behaviors before and after the intervention. Participants were adults hospitalized with systolic heart failure (LVEF ≤ 40%) who meet specific clinical criteria. Each participant received a 30-minute individualized education session at discharge, covering key self-care topics such as medication adherence, symptom monitoring, fluid restriction, and dietary modifications. Printed educational materials from the American Heart Association were also provided.
To measure outcomes, participants completed the European Heart Failure Self-care Behavior Scale (EHFScB-9) before and after the intervention. Thirty-day readmission data was collected through a retrospective review of hospital records. The study aimed to determine whether teach-back education improved self-care behaviors and reduced 30-day readmission rates.
This project was reviewed and exempted by the Nova Southeastern University Institutional Review Board under Exempt Category 2. It aligned with national goals to improve patient education, reduce preventable readmissions, and enhance the quality of care for individuals with heart failure.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Atlantis, Florida, United States, 33462
- HCA Florida JFK Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 years and older
- Diagnosed with systolic heart failure with a left ventricular ejection fraction (LVEF) ≤ 40%
- Classified as New York Heart Association (NYHA) Class II, III, or IV
- Categorized as American College of Cardiology/American Heart Association (ACC/AHA) Stage C or D
- Currently hospitalized at the project site
- Able to read and understand English at an 8th grade reading level
- Have access to a smartphone or tablet capable of scanning QR codes and connecting to the internet
- Provide voluntary informed consent via the REDCap platform
Exclusion Criteria:
- Cognitive impairment
- Non-English speaking
- Unwilling to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Teach-Back Education Intervention
Participants in this arm received a structured discharge education session using the teach-back method.
The session was delivered in person at hospital discharge and covered key heart failure self-care behaviors, including medication adherence, symptom monitoring, fluid restriction, and dietary modifications.
Participants were asked to restate instructions in their own words to confirm understanding.
Printed educational materials from the American Heart Association were also provided.
|
A structured, 30-minute discharge education session delivered in person using the teach-back method.
Participants are asked to restate instructions in their own words to confirm understanding.
The session covers key heart failure self-care behaviors including medication adherence, symptom monitoring, fluid restriction, and dietary modifications.
Printed educational materials from the American Heart Association are also provided.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Heart Failure Self-Care Behaviors (EHFScB-9 Total Score)
Time Frame: Baseline (pre-intervention) and immediately post-intervention on the same day, up to 35 minutes after the start of the education session.
|
The 9-item European Heart Failure Self-Care Behavior Scale (EHFScB-9) was used to assess self-care behaviors.
Each item is scored on a 5-point Likert scale ranging from 1 ("completely agree") to 5 ("do not agree at all"), producing a total score range of 9 to 45.
The outcome represents the change in total EHFScB-9 score from baseline (pre-intervention) to immediately post-intervention following the discharge education session.
Lower total scores indicate better self-care performance (more consistent adherence to recommended behaviors), while higher total scores indicate poorer self-care performance (less consistent adherence).
|
Baseline (pre-intervention) and immediately post-intervention on the same day, up to 35 minutes after the start of the education session.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With 30-Day Heart Failure Readmission
Time Frame: Assessed during the 30-day period following hospital discharge.
|
Readmission status was determined from hospital records and participants were classified as readmitted (Yes) or not readmitted (No) within 30 days of discharge.
Data are displayed as counts in the results table.
|
Assessed during the 30-day period following hospital discharge.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Virginia Waters, Ph.D., MSN, MBA, RN, CNE-BC, Nova Southeastern University, Ron and Kathy Assaf College of Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-398
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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